Rabeprazole Sodium/Metronidazole/Amoxicillin

TITUSVILLE, N.J., July 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe. These applications reflect Janssen’s longstanding commitment to address the needs of adults, adolescents and children affected by the global HIV epidemic.If the new applications are approved, EDURANT®, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children. “We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”The expanded pediatric applications are supported by data from the Phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed that EDURANT®, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.The expansion of the EDURANT® indication would mark the latest step forward in Janssen’s efforts to make its HIV medicines available to young people living with HIV. In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.Johnson & Johnson’s Commitment to HIVIn addition to driving innovation in HIV care, Johnson & Johnson also works with vulnerable communities on the global frontlines of the HIV epidemic, and has supported collaborative initiatives like Positively Fearless, the DREAMS Partnership and the MenStar Coalition. We also support the New Horizons Collaborative, which is working to address the unmet needs of HIV treatment-experienced children, adolescents and young adults in sub-Saharan Africa.To learn more about Johnson & Johnson’s commitment to combating HIV, please visit jnj.com/HIV.About EDURANT®EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. Limitations of Use:EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.Please see full Prescribing Information for important safety information.Important Safety InformationWho should not take EDURANT®?Do not take EDURANT® if you also take:What should I tell my healthcare provider before taking EDURANT®?Before taking EDURANT®, tell your healthcare provider about all your medical conditions, including if you:Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT®.Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® with other medicines.How should I take EDURANT®?What are the possible side effects of EDURANT®?EDURANT® can cause serious side effects including:Stop taking EDURANT® and get medical help right away if you develop a rash with any of the following signs or symptoms:Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.You are encouraged to report side effects of prescription drugs to the FDA. www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).Please read the full Product Information for EDURANT® and discuss any questions you have with your healthcare provider.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Sciences Ireland Unlimited Company and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and other treatments for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland Unlimited Company, Janssen Research & Development, LLC, the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.###© Janssen Therapeutics, Division of Janssen Products, LP

The tablet formulation of Calquence received approval to treat chronic lymphocytic leukaemia. Credit: Nephron / Wikimedia. The European Commission (EC) has granted approval for AstraZeneca ’s tablet formulation of Calquence (acalabrutinib) to treat chronic lymphocytic leukaemia (CLL) in adult patients. The selective Bruton’s tyrosine kinase (BTK) inhibitor Calquence binds covalently to BTK, and then inhibit its activity. EC’s approval comes after the Committee for Medicinal Products for Human Use’s positive opinion. It is based on the data obtained from the ELEVATE-PLUS trials, which include three single-dose, open-label, cross-over Phase I trials conducted in 116 healthy participants. The studies established bioequivalence between acalabrutinib 100mg tablets and acalabrutinib 100mg capsules. They assessed the proton pump inhibitors (PPI) effect of acalabrutinib tablets given in the presence against the absence of PPI rabeprazole. Findings demonstrated that the Calquence capsule and tablet formulations are bioequivalent in the trials. AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “The Calquence tablet formulation underscores our commitment to understanding the needs of the chronic lymphocytic leukaemia community and providing patient-oriented treatment solutions. “Today’s approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially benefit from this medicine.” In the US, Calquence received approval as a capsule and tablet formulation to treat CLL, small lymphocytic lymphoma (SLL) and relapsed or refractory mantle cell lymphoma (MCL) patients. In a separate development, AstraZeneca has received EC approval for its Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations to treat advanced liver and lung cancers. The combination of Imfinzi with Imjudo received approval for the first-line treatment of advanced or unresectable hepatocellular carcinoma (HCC) in adult patients. Imfinzi along with Imjudo and platinum-based chemotherapy, received approval to treat metastatic (Stage IV) non-small cell lung cancer (NSCLC) in these patients. The two regulatory approvals are based on the data obtained from the Phase III HIMALAYA and POSEIDON trials.