FDA Action Alert: Incyte, Arcutis Await Decisions in Vitiligo, Psoriasis
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The U.S. Food and Drug Administration’s calendar for PDUFA dates is relatively quiet for the middle of July, although it picks up heading into August. Here’s a look at target action dates for the next two weeks.
Incyte’s Opzelura for Vitiligo
Incyte Corporation has a target action date of July 18, 2022, for its supplemental New Drug Application (sNDA) for Opzelura (ruxolitinib cream) to treat vitiligo. The original date was three months earlier, but the agency requested more data, decided it was a major amendment and extended the PDUFA goal date. Vitiligo is a skin condition that causes the skin to lose its pigment, leading to discolored patches.
The submission contained data from the pivotal Phase III TRuE-V program, which included the TRuE-V1 and V2 trials. They evaluated the drug compared to vehicles in more than 600 adolescents and adults 12 years and older with non-segmental vitiligo.
In March, Incyte presented Phase III TRuE-V data at the 2022 American Academy of Dermatology (ADD) Annual Meeting, which was held in Boston. The 52-week data was built on 24-week results as well as data from the 24-week double-blind and 28-week treatment extension periods of the Phase III TRuE-V1 and TRuE-V2 trials.
The 52-week analysis demonstrated that patients using the 1.5% cream twice daily had clinically meaningful facial and total body repigmentation. At Week 52, about 50% of patients achieved 75% or greater improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared to F-VASI75 improvement from baseline reported for those patients at Week 24, which was the primary endpoint, which was about 30%.
At the time, Jim Lee, M.D., Ph.D., group vice president of Inflammation & Autoimmunity at Incyte, stated, “The positive 52-week results in facial and total body repigmentation seen with ruxolitinib cream in our pivotal Phase III TRuE-V program, which were presented today at the 2022 AAD meeting, add to the robust data showing ruxolitinib cream has the potential to be a meaningful treatment option for those with vitiligo.”
Opzelura is a JAK1/JAK2 inhibitor approved in the U.S. for mild to moderate atopic dermatitis in non-immunocompromised people 12 and older whose disease is not adequately controlled via topical prescription drugs or when they are not recommended.
Arcutis’ Roflumilast for Psoriasis
Arcutis Biotherapeutics has a target action date of July 29 for its NDA for roflumilast cream for psoriasis in adults and adolescents. The cream is a once-daily topical formulation of the drug, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that stimulates overactive immune responses.
The NDA is built on data from the company’s Phase III program and long-term Phase IIb open-label study. DERMIS 1 and 2 were identical Phase III trials. The drug hit the primary endpoints and had an Investigator Global Assessment (IGA) success rate of 42.4% compared to a vehicle rate of 6.1%, and 37.5% compared to a vehicle rate of 6.9%, in DERMIS 1 and 2, respectively.
“Topical treatments are the standard therapies for the majority of psoriasis patients, but they often come with compromises between efficacy, tolerability and long-term use,” said Dr. Patrick Burnette, M.D., Ph.D., Arcutis’ chief medical officer in a December 2021 statement. “With these challenges in mind, we developed roflumilast cream as a formulation for chronic use anywhere on the body, including the face and sensitive intertriginous areas.”