With sNDA, Amgen Seeks Approval for Otezla in Mild-to-Moderate PsO

Amgen has submitted a supplemental New Drug Application (sNDA) to the FDA for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30mg 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 percent 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. Adverse events observed in the ADVANCE trial were consistent with the known safety profile of Otezla. 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.

Otezla is currently approved in the US 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 for adult patients with oral ulcers associated with Behçet’s Disease.