预约演示

FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata

2022-06-14

合作疫苗

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

EliyLilly and Companyoto/Eli Lilly and CoElinLilly and Companyi Lilly and Company)

INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.1 The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day. Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day.1 OLUMIANT is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.1

Incytee with alopecia areEli,Lilly and Companynd other healtElirLilly and Companybeen looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease. Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities," 2-4 said Brett King, M.D., Ph.D., F.A.A.D., associate professor of dermatology at Yale School of Medicine and lead investigator of the BRAVE-AA program. "I am so happy that adults with severe alopecia areata can now take OLUMIANT, a once-daily pill. The results of clinical trials are remarkable, as one in five adults taking OLUMIANT 2-mg/day and one in three taking OLUMIANT 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking OLUMIANT 4-mg/day with substantial eyebrow or eyelash hair loss."1

The approval was based on Lilly's BRAVE-AA1 Eli Lilly and Company the largest PhasIncyte clinical trial program completed to datU.S. Food and Drug Administration (FDA)y of OLUMIANT OLUMIANT adbaricitinibs with severe AA (≥50% scalp hair loss as defined by a Severity of Alopecia Tool (SALTalopecia areata (AA)s the studies at 36 weeks, 17-22% of patients taking OLUMIANT 2-mg/daOLUMIANT-35% of patients taking OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.1 Additscalp hair loss of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for OLUMIANT OLUMIANT were not statistically significant under the multipliJAK inhibitors JAKy control plan for BRAVE-AA2.1cyclosporine

Among patientalopecia areataial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.1Alopecia areata hair loss Yale School of Medicine alopecia areata OLUMIANT OLUMIANT OLUMIANT OLUMIANT

The BRAVE-AA clinical progLillyvaluated the safety profile of OLUMIANT.1 Few patients discontinued treatment due to adverse events (average of 2.2% across both studies) in OLUMIANTeek placebo-controlled period and the majorityscalp hair lossmergent adverse events were mAlopeciaoderate in severity.8 The most commonly reported adverse reactions (≥1%) were upper OLUMIANTory tract infections, headache, acne, hiOLUMIANTsterol levels, increases in blood markers related to the muscle, urinary tract infections, elevated liver enzyme levels, inflaOLUMIANTof hair follicles, fatigue, lower respirOLUMIANTact infections, nausea, genital yeast infection, low red blood cell counts, low white blood cell countsOLUMIANTnal pain, shingles and weight increase.1 The U.S. FDA-approved labeling for OLUMIANT includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.1 See below for full Important Safety Information.

"Today marks a milestone with the first-evereyelash hair losstemic treatment for alopecia areata patients, who face significant challenges every day iOLUMIANT limited public knowledge about the disease, a lack of treatment options and social stigma,"9 said Nicole Friedland, president and chief executive officer, National Alopecia Areata Foundation (NAAF). "The approval of OLUMIANT can spark hope for many patients and encourage new treatment conversations with their doctors. NAAF wants more choices for our patient community and with the approval of OLUMIANT, there are now new treatment expectations being established in alopecia areata care."

Lilly is committed to ensuring patients have access to much-neOLUMIANT.1ines and is working with insurers to do so. Through the OLUMIANT TogetherTM support program, Lilly offers a savings card for eligible commercially insured patients* to help with out-of-pocket costs where they pay as little as $5/month if covered by their insurance provider or $25/monupper respiratory tract infectionsheheadache cacneis available at specialty pharmacies, and in the coming days will be availablurinary tract infectionsNT.com.inflammation fatigue lower respiratory tract infections nausea genital yeast infection abdominal pain shingles OLUMIANT infections malignancy thrombosis.1

"There is a significant unmet medical need for people with alopecia areata given alopecia areata been an FDA-approved systemic medicine. In fact, a study published in 2017 of 1,083 people with AA showed that nearly 80 percent were unsatisfied with their treatment options,"10 said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and OLUMIANTstomer officer. "Our mission is to make life better for people living with debilitating immune-mediated diseases. OLUMIANT's approval is a historic moment, and we're deligOLUMIANTut what it can mean for adults with severe alopecia areata."alopecia areata

Lilly more about OLUMIANT; view the 2-mg and 4-mg product photos and brand logo.OLUMIANT Lilly

OLUMIANT is a once-daily, oral JAK inhibitor discovered by alopecia areatansed to Lilly and is available through specialty pharmacies nationwide. Lilly also expects regulatory decisions for OLUMIANT in AA in the European Union and Japan in 2022.Lilly Lilly Immunology Lilly USA immune-mediated diseases OLUMIANT alopecia areata

About BRAVE-AA1 aOLUMIANT-AA2

OLUMIANT double-blind, placebo-JAK inhibitor JAKtrolled Phase 3 trials, 1Incyteatients with seveLilly were randomized to receive once-daily OLUMIANT 2-mg, OLUMILilly-mg or placebo.OLUMIANT

The primary endpoint was the proportion of patients achieving SALT ≤20 (i.e., 80% or more scalp hair coverage) at Week 36.1 Across both studies, 17-22% of patients taking OLUMIANT 2-mg/day (BRAVE-AA1=22% [n=40/184]; BRAVE-AA2=17% [n=27/156]) and 32-35% of patients treated with OLUMIANT 4-mg/day (BRAVE-AA1=35% [n=99/281]; BRAVE-AA2=32% [n=76/234]) achieved 80% or more scalp hair coverage, compared to 5% (n=10/189) and 3% (n=4/156) of patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (p≤0.001 for all comparisons to placebo).

Additionally, 11-13% of patients taking OLUMIANT 2-mg/day (BRAVE-AA1=13% [n=23/184]; BRAVE-AA2=11% [n=17/156]) and 24-26% of pOLUMIANTtaking OLUMIANT 4-mg/day (BRAVE-AA1=26% [n=73/281]; BRAVE-AA2=24% [n=55/234]) achieved 90% or more hair coverage, compared to 4% (n=7/189) and 1% (n=1/156) of patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (p1,8 SALT 10 (90% hair coverage) results for OLUMIANT 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2.8

Indications and Usage for OLUMIANT (baricitinib) tablets (in the United States)OLUMIANT OLUMIANT

OLUMIANT is indicated for the treatment OLUMIANT patients with severe alopecia areata.OLUMIANT

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

OLUMIANT is indicated for the treatment of adult patients with moderatalopecia areata active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

Limitations of UseJAK inhibitors JAK cyclosporine

OLUMIANTcommended for use in combination with other JAK inhibitors, biologic disease-mactive rheumatoid arthritiss (DMARDs), or with potent immunosuppressants such atumor necrosis factor (TNF) blockers tumor necrosis factor (TNF)rine.

OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinJAK inhibitors JAK tabletsazathioprine cyclosporine

OLUMIANT SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARCOVID-19LAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONSOLUMIANT baricitinib

Patients treated INFECTIONSant are at riMALIGNANCYeloping serious infections that may lead toTHROMBOSISzation or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

Active tINFECTIONSs (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.

Invasive fungal infectOlumiantcluding candidiasis and pneumocystosinfectionsts with invasive fungal infections may present with disseminaterheumatoid arthritis (RA) disease.infections methotrexate infection Olumiant infection infections

Active tuberculosis (TB)her infections due to opppulmonary or extrapulmonary disease Olumiant active tuberculosis COVID-19 latent TB Olumiant latent infection Olumiant

Invasive fungal infectionsks and benefcandidiasisiant pneumocystosisating therapy ininvasive fungal infectionsrecurrent infection.

Closely monitor patients forinfectionsopment of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

The most common serious infections reported wOlumiantiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avoid use of Olumiant in patients with an active, serious infection, iinfectionlocalized infections. Consider thOlumiantand benefits of treatment prior to initiating Olumiant in patients: with chronlatent TB infectionection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.

The risks and benefits oinfectionst with OlumiantOlumiantD-19 patiepneumoniaotherpes zostert infeurinary tract infectionered.opportunistic infections tuberculosis multidermatomal herpes zoster esophageal candidiasis pneumocystosis acute histoplasmosis cryptococcosis Olumiant methotrexate

Consider antiOlumiantapy prior to initiation of Olumiant iinfections with a hislocalized infectionstive TB in whom an adequate course of treatment cannot be confirmedOlumiantr patients with a negative test for latent TB but who have risk factors for TB infection.infection tuberculosis endemic mycoses infection

Viral reactivation, including cases of heOlumiantus rCOVID-19ion (e.g., herpes zoster), were infectionsn clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MORTALITYOlumiant latent TB TB infection

In a large, randomized, postmarketing safety study in RA patients 50 yeaherpes zoster older with at least one cardiovascular riOlumiantr comparing another Januherpes zoster) inhibitor Olumiant necrosis factor (TNF) blockers, a higher rate of allOlumiantortachronic viral hepatitiscardiovascular death, was observed with the JAK inhibitor.Olumiant

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.

MALIGNANCIESJanus kinase (JAK)tumor necrosis factor (TNF) blockers tumor necrosis factor (TNF)JAK inhibitor JAK

Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treatOlumiantanother JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.

Lymphoma the benefimalignancies for the individual patient prior to initiatiOlumiantntinuing therapy with Olumiant, particJAK inhibitor JAKrly in patients with a known malignanciesother than snon-melanoma skin cancer [NMSC]ents who develop a malignancy, and patients who are current or past smokers.

NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is reclymphomasfor patients who are at increased risk for JAK inhibitor JAKn cancer.lung cancers overall malignancies JAK inhibitor JAK

MAJOR ADVERSE CARDIOVASCULAR EVENTSOlumiant malignancy NMSC malignancy

In RA patients 50 years of age and older with at lOlumiant cardiovascular risk factor treated with another JAK inhibitor, a higher rate of majorskin cancerrdiovascular events (MACE) (defined as cardiovascular death, myocardial infarction [MI], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.

THROMBOSISJAK inhibitor JAK myocardial infarction [MI]stroke Olumiant myocardial infarction stroke

Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an inOlumiantincidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.

THROMBOSISTIVITY

Thrombosissuch as angideep venous thrombosis (DVT)that pulmonary embolism (PE)ensitivity have been observed in patients receiving Olumiant, includingOlumiant reactions. If a serious hypersensitivity reaction occuarterial thrombosistinue Olumiant while evaluating the potential causes of the reaction.JAK inhibitor JAK thrombosis Olumiant Olumiant thrombosis

GASTROINTESTINAL PERFORATIONS

Gastrointestinal pangioedemas urticaria reporrashin Olumiant clinicdrug hypersensitivitylumiant-treated patients who may be at incOlumiantisk for gastrointestinal perforation (e.g., hypersensitivity reactionf diverticulitis). Promptly evOlumiantatients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Gastrointestinal perforationsent was associated withOlumianteased incidence of neutropeOlumiantolute neutrophil count [ANC] 3) compared to placebogastrointestinal perforationhereafter according to routine patidiverticulitis.gastrointestinal perforation

In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC 3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC 3.

Neutropenia – Olumiant lymphocyte count (ALC) 3 were reported in Olumiant clinineutropenia Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or alopecia areata (AA) or interrupt Olumiant treatmentOlumiantents with an ALC 3. In patients with COVID-19, avoid inCOVID-19 or interrupt Olumiant treatmentOlumiantents with an ALC 3.

Anemia – Decreases in hemoglobin levels to Liver Enzyme ElevationOlumiantiant treatment was associated with increased incidence of liver enzyme elevation compared to infectionIncreases of alanine transOlumiant(ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine Olumiantmanagement. Promptly investigate the cause of liver enzCOVID-19ation to identify potential caseOlumiantg-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

AnemiaElevations – Treatment with Olumiant was associated with increaOlumiantipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients accordingOlumiantical guidelines for the management of hyperlipidemia.

VACCINATIONSdrug-induced liver injury AST drug-induced liver injury Olumiant

Avoid use of live vaccines with OlOlumiantUpdate immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.Olumiant hyperlipidemia

ADVERSE REACTIONS

In RA trials, the most common adOlumiantactions (≥1%) reported with Olumiant were: upper respiratory tract inOlumiant, nausea, herpes simplex, and herpes zoster.

In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC 3), DVT, PE, and urinary tract infection.

In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nauseaheherpes simplexipidemherpes zosterphosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.

PRECOVID-19ND LACTATIONOlumiant AST thrombocytosis neutropenia DVT urinary tract infection

Based on animal studies, Olumiant may cause fetal harm when administOlumianting preupper respiratory tract infectionswoheadacheepacnecthyperlipidemiaof the potential risk to a fetus. Curinary tract infectionsng and prevention for womenfolliculitistifatiguentlower respiratory tract infectionsd nausea tgenital Candida infections fanemiaayneutropenia labdominal pain herpes zoster

HEPATIC AND RENAL IMPAIRMENT

Olumiant is not recommendOlumianttients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate [eGFR] 1.73m2).Olumiant

Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR 1.73m2.

Olumiantlick to access full Prescribing Information, including Bohepatic impairmentSerious Infrenal impairmentty, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.

OlumiantSI ALL 13JUN2022COVID-19 hepatic impairment Olumiant COVID-19 end-stage renal disease

*Savings Card Terms and ConditionsInfections Malignancy Thrombosis

Offer good until 12/31/2024 or up to 36 months from patient qualification into the program, whichever comes first. Patients must first use their card by 12/31/2022. Patients must have coverage for Olumiant through their commercial drug insurance to pay as little as $5 for a 30-day supply of Olumiant. Offer subject to a monthly cap and a separate annual cap. Patients must have commercial drug insurance and prescription consistent with FDA-approved product labeling to pay as little as $25 for a 30-day supply of Olumiant. Participation in the $25 program requires submission of a prior authorization (PA). If coverage is denied, an appeal must be submitted prior to the 5th month fill. A new PA and appeal or medical exception (ME) must be submitted every 12 months or as required by Lilly to verify coverage status and potential eligibility for the $5 program. Monthly and annual caps are set at Lilly's absolute discretion and may be changed by Lilly with or without notice. Patient is responsible for any applicable taxes, fees, or amounts exceeding monthly or annual caps.

This offer is invalid for patients without commercial drug insurance or whose prescription claims for Olumiant are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state patient or pharmaceutical assistance program. Offer void where prohibited by law and subject to change or discontinue without notice. Card activation is required. Subject to additional terms and conditions, which can be found at olumiant.com/olumiant-together.

About OLUMIANT®Olumiant Olumiant Olumiant Lilly Lilly Lilly

OLUMIANT, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is apprOlumiantthe U.S. and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis. FDA approval was granted for OLUMIANT for the treatment of certain hospitalized adult patients with COVD-19 in May 2022. Marketing authorization for OLUMIANT in COVID-19 has been granted in six other countries including Japan and Switzerland. The U.S. FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information here.

In DecOLUMIANT09, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of OLUMIANT and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

OLUMIANTllyJAK inhibitor JAK Incyte Lilly rheumatoid arthritis FDA OLUMIANT COVD-19 OLUMIANT COVID-19 FDA OLUMIANT Infections Malignancy Thrombosis

Lilly unites carinLillyh disIncyte to create medicines that make life better for people around the world. We've been pioneering life-changing discoveOLUMIANT nearly 150 years, and today our medicines help morinflammatory and autoimmune diseasesglobe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram, Twitter and LinkedIn. P-LLY

About Lillye

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.diabetes obesity Alzheimer's disease immune system disorders cancers Lilly.com

OLUMIAIncyted OLUMIANT TogetherTM are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Incytetrademarks listed are the property of their respective owners.Incyte

OLUMIANT OLUMIANT Eli Lilly and Company

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for alopecia areata and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that OLUMIANT will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

Olumiant. Prescribing Information. Lilly USA, LLC.

Pratt CH, King LE Jr, Messenger AG, et al. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011.OLUMIANT baricitinib alopecia areata Lilly Incyte OLUMIANT Lilly Incyte Lilly Incyte

Olumiant, Sallee BN, Tejeda CI, et Lilly USA, LLC.e inhibitors for treatment of alopecia areata. J Invest Dermatol. 2018;138:1911-1916.

Strazzulla LC, Wang EHC, Avila L, et al. Alopecia areata: disease characteristics, clinical evaluation, and new perspectives on pathogenesis. J Am Acad Dermatol. 2018;78:1-12.

Pfizer Inc. (2018, November - 2022, FebJanus kinase inhibitors Janus kinase6651600 for the Treatment of alopecia areata (ALLEGRO-2b/3). Identifier NCT03732807. https://clinicaltrials.gov/ct2/show/results/NCT03732807

Concert Pharmaceuticals (2020, August). A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1) (THRIVE-AA1). Identifier NCT04797650. https://clinicaltrials.gov/ct2/show/NCT04797650.

Pfizer Inc.rmaceuticals (2021, March). A Phase PF-06651600Evaluate the Efficacy Alopecia AreataTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA2) (THRIVE-AA2). Identifier NCT04518995. https://clinicaltrials.gov/ct2/show/NCT04518995.

Concert Pharmaceuticals, LLC. DOF-BA-US-0075.CTP-543 Alopecia Areata

Concert Pharmaceuticalsstration. The voice of the patient: a series of reports from the U.S. FCTP-543 Drug Administration's (FDA) patient-focuseAlopecia Areataent initiative: Alopecia Areata. Meeting date: September 11, 2017; report date: 2018. https://www.fda.gov/media/112100/download. Accessed 18 March 2022.

Hussain ST, MoLilly USA, LLC.r PJ, et al. Utilization of mental health resources and complementary and alternative therapies for alopecia areata: a U.S. survey. Int J Trichology. 2017;9(4):160-164.

SOURCE Eli Lilly and Company; Incytealopecia areata