FDA Accepts Amgen's Supplemental New Drug Application for Otezla (apremilast) in Mild-to-Moderate Plaque Psoriasis

Compiled by Fan Dongdong

Recently, Amgen announced that the U.S. FDA has accepted and is reviewing its supplemental new drug application (sNDA) for Otezla (apremilast) for the treatment of adult patients with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has initially set the Prescription Drug User Fee Act (PDUFA) date for this application as December 19, 2021.

This application is primarily supported by the results of the multicenter, randomized, controlled, Phase 3 double-blind ADVANCE trial (PSOR-022, NCT03721172), which primarily evaluated the efficacy and safety of Otezla in patients with mild-to-moderate plaque psoriasis characterized by 2%–15% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of 2–15, and a static Physician’s Global Assessment (sPGA) score of 2–3. A total of 595 patients were enrolled in the trial; 297 patients received Otezla at a dose of 30 mg twice daily during the initial 16 weeks, while the remaining 298 patients received placebo. Upon completion of the 16-week treatment period, all patients received Otezla in an open-label extension phase through Week 32.

The trial results demonstrated that, compared with placebo, a significantly higher proportion of patients in the Otezla treatment group achieved an sPGA 0/1 response at Week 16 (21.6% vs. 4.1%, p<0.0001). Furthermore, clinical improvement was sustained through Week 32, and the trial met its primary endpoint. Regarding secondary endpoints, compared with placebo, patients in the Otezla group showed at least a 75% improvement from baseline in the affected body surface area (BSA) at Week 16. Additionally, the total BSA score improved from baseline, and the Psoriasis Area and Severity Index (PASI) total score also demonstrated corresponding improvement from baseline in patients with psoriasis.

In the ADVANCE trial, the safety profile of Otezla was consistent with data reported in previous Otezla clinical trial programs. The most common (≥5%) treatment-emergent adverse events (TEAEs) in either treatment group were diarrhea (14.3%), headache (12.9%), nausea (12.7%), upper respiratory tract infection (8.5%), and nasopharyngitis (6.8%).

In August 2019, Amgen acquired Otezla, an oral, selective phosphodiesterase 4 (PDE4) inhibitor, from Celgene and BMS for $13.4 billion. The drug currently has three approved indications in the United States: 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. If the current supplemental New Drug Application (sNDA) is ultimately approved, sales revenue for Otezla is expected to increase further.

According to the latest 2020 financial report released by Amgen, Otezla generated nearly $2.2 billion in sales revenue for the company in 2020. If the supplemental New Drug Application (sNDA) is ultimately approved, Otezla’s sales revenue is expected to continue growing, with market analysts previously projecting that it could exceed $3 billion by 2023.

Reference Source:

1.A Accepts Amgen's Supplemental New Drug Application For Otezla® (apremilast) For Adults With Mild-To-Moderate Plaque Psoriasis

2.Amgen: FDA To Review SNDA For Otezla - Quick Facts