FDA accepts for review sNDA for Otezla to treat mild-to-moderate plaque psoriasis patients who are candidates for phototherapy or systemic therapy. Amgen

Amgen has announced that the 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. The sNDA, submitted on February 19, 2021, is based on data from the Phase III 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.