The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for apremilast, a phosphodiesterase 4 inhibitor, for the treatment of adults with mild to moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
The sNDA is supported by data from the multicenter, double-blind, placebo-controlled phase 3 ADVANCE trial (ClinicalTrials.gov: NCT03721172), which evaluated the efficacy and safety of apremilast in 595 adults with mild to moderate plaque psoriasis. Patients were randomly assigned 1:1 to receive either apremilast 30mg orally twice daily or placebo for the first 16 weeks followed by all patients receiving apremilast in an open-label extension phase through week 32. The primary endpoint was the proportion of patients with static Physician’s Global Assessment (sPGA) response of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at week 16.
Results showed that apremilast met the primary endpoint achieving a statistically significant improvement in sPGA response at week 16 compared with placebo. In addition, the study met key secondary endpoints at week 16, including at least 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. These clinical improvements were maintained through week 32.
The safety profile of apremilast was consistent with that seen in previous studies. The most common adverse events reported in either the apremilast or placebo treatment arms were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection.
“Based on the positive phase 3 ADVANCE data, we believe [apremilast] 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, MD, executive vice president of Research and Development at Amgen.
A Prescription Drug User Fee Act (PDUFA) target date of December 19, 2021 has been set for the application.
Apremilast is marketed under the trade name Otezla® and is currently approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, and for oral ulcers associated with Behçet’s disease.
FDA accepts Amgen’s supplemental New Drug Application for Otezla® (apremilast) for adults with mild-to-moderate plaque psoriasis. [press release]. Thousand Oaks, CA: Amgen; May 5, 2021.