A supplemental New Drug Application (sNDA) has been submitted to the Food and Drug Administration (FDA) for apremilast (Otezla; Amgen), a phosphodiesterase 4 (PDE4) 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 end point 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 end point achieving a statistically significant improvement in sPGA response at week 16 compared with placebo. In addition, the study met key secondary end points 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.
According to the Company, detailed findings from the trial will be submitted for presentation at an upcoming medical meeting.
“Results from the ADVANCE trial demonstrated the potential of Otezla to provide an oral, non-biologic option for these patients,” said David M. Reese, MD, executive vice president of Research and Development at Amgen. “We look forward to working with the FDA to potentially expand access to Otezla and deliver on our commitment to improve outcomes for people living with mild-to-moderate plaque psoriasis.”
Otezla 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.
Amgen submits supplemental New Drug Application for Otezla® (apremilast) for adults with mild-to-moderate plaque psoriasis. [press release]. Thousand Oaks, CA: Amgen; February 22, 2021.