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Incyte's Opzelura clears skin in children with atopic dermatitis, but safety remains a question

2023-07-12

临床3期上市批准临床结果

In the topical treatment of atopic dermatitis, Incyte's Opzelura cream will likely have to compete with Roivant Sciences's Vtama and Arcutis' Zoryve.

Fighting for a place in the atopic dermatitisc IncyteitiOpzelura creamte hopes to reach younger patientsRoivant Scienceshibitor creamArcutisra. A new pivotal trial win may help the company reach that goal, but safety concerns may present a challenge in a forthcoming market clash.

In a phase 3 trial in children ages 2 toatopic dermatitisermatitisIncytelura cleared skin in significantly more paJAK inhibitor JAKnts than a nonmedOpzeluraopical control did, Incyte said Tuesday. The drug, a topical version of the ruxolitinib ingredient used in Jakafi, is currently approved in eczema patients 12 and older.

The trial, called TRuE-AD3, showed that Opzelura atopic dermatitiserOpzeluraat achieving clear or almost clear skin with at least a two-point improvement on the IIncytegators’ Global Assessment Treatment Success (IGA-Truxolitinib the eighth week. ThJakafil, therefore, hit its primaeczemapoint.

The readout comes a few weeks after RoivOpzelurances’ Dermavant said its rival cream Vtama hit the goals of two phase 3 atopic dermatitis trials in patients as young as 2. Arcutis Biotherapeutics also recently touted a win for its Zoryve cream in two phase 3 trials in eczema patients 6 years of age and older, with a separate study in children ages 2 to 5 expected to report topline data later this year.

In Opzelura’s case, a JAK classwide Roivant Sciencesd Dermavanty cross to bear.atopic dermatitis Arcutis Biotherapeutics eczema

When approving OpzelurJAKor eczema in 2021, the FDA slapped a box warning on the topical drug’s label. The warning discusses increased cardiovascular disease risks, serious infections and other side effects that were observed in studies of oral JAK inhibitors.

For the originaOpzeluraal ineczemants 12 years aFDAabove, Opzelura is made of 1.5% ruxolitinib and given twice daily. For the TRuE-AD3 cardiovascular diseasents, Incyte testinfectionsat dose and a lower 0.75% strength.JAK inhibitors JAK

The company didn’t share specific efficacy or safety data Opzelura the drug’s overaruxolitinibrofile is “consistent with previous data” with no new safety signalsIncyteved. The trial remains ongoing to collect long-term safety data.

Incyte will discuss the data with regulatory agencies to determine the next steps, Jim Lee, M.D., Incyte’s VP for inflammation & autoimmunity, said in a statement Wednesday. By the company’s estimates, eczema affects about 2 million to 3 million children ages 2 to 11 and more than 21 million people 12 years and older.

Incyteile, Incyte's Opzelura could use a market expansion. The drug’s sales disappointed in the fiIncytearter, cominflammation7 mautoimmunityn 8% sequential decline. At that time, Leerink Partners analyeczemated that Vtama and Zoryve are expected to enter the eczema market by the second half of 2024. These two drugs don’t have box warnings in their approved plaque psoriasis uses.

Incyte has Incyteeen suffering from a high discount rate for Opzelura at around 50% to 60% as of the first quarter. Payers could leverage the potential competition to push for bigger discounts, the Leerink team said in a May note.eczema plaque psoriasis

Incytera at the 1.5% strength currently boasts the strongest Opzelura data among the three agents, although cross-trial comparisons can be problematic, the Leerink team noted in a May report. Vtama’Leerinkacross a wider age group looked comparable to Opzelura at the 0.75% strength in the previous TRuE-AD trials in older patients.

Opzeluraama’s readout, Leerink analysts put the Dermavant drug’s peak U.S. sales at above $1.5 billion. By comparison, the team figured Opzelura could reachLeerink peak sales of $721 million.

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