FDA Accepts Amgen’s sNDA For Otezla ®
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla ® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021.
“Otezla has been prescribed to hundreds of thousands of patients with moderate-to-severe plaque psoriasis. Based on the positive Phase 3 ADVANCE data, we believe it could play an important role in addressing the unmet need for adults affected by mild-to-moderate plaque psoriasis who have had challenges managing their disease with existing topical therapies alone,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “The FDA’s acceptance of this sNDA for Otezla is a significant milestone toward achieving our goal of potentially providing the first and only oral treatment option for the underserved mild-to-moderate patient population.”
The sNDA, submitted on February 19, 2021, is based on data from the Phase 3 ADVANCE trial, a multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla ® (apremilast) in adults with mild-to-moderate plaque psoriasis, which demonstrated that oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician’s Global Assessment (sPGA) response at week 16 compared to placebo. Otezla also demonstrated statistically significant improvements in key secondary endpoints compared to placebo, including achieving at least a 75% improvement from baseline in the percent of affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16. These clinical improvements were maintained through week 32.
The safety profile of Otezla in the ADVANCE trial was consistent with previously reported data from Otezla clinical trial programs. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea, nasopharyngitis and upper respiratory tract infection.
Detailed results were recently presented at the American Academy of Dermatology Virtual Meeting Experience 2021.
In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet’s Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis in the U.S.