AMGEN INC — Otezla FDA Review (NDA/BLA 205437, 2023)
Amgen Inc. · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Otezla (apremilast) approval on December 20, 2021, for active psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease. It summarizes efficacy and safety across these indications, including clinical trial results for ACR responses, PASI-75, sPGA, and oral ulcer improvement. The report also covers pharmacokinetic data, risk summaries, and adverse reactions. Regulatory aspects, such as labeling changes, pediatric assessments, and medication error prevention, are addressed. Specifically, it highlights the BCT-002 trial for oral ulcers and Study PSOR-022 for mild to moderate plaque psoriasis, detailing their methodologies and efficacy endpoints. The Division of Dermatology and Dentistry found proposed labeling revisions acceptable.
Key findings — cited to the page
| Approval Date | December 20, 2021 | OTEZLA · p.1 |
| Discontinuation due to depression or depressed mood | 0.3 % | OTEZLA (Psoriatic Arthritis) · p.11 |
| Indication | Adult patients with oral ulcers associated with Behçet’s Disease | OTEZLA · p.1 |
| Indication | Adult patients with active psoriatic arthritis | OTEZLA · p.1 |
| Indication | Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy | OTEZLA · p.1 |
| Initial U.S. Approval | 2014 | OTEZLA · United States · p.9 |
| Recent Major Changes - Indications and Usage, Plaque Psoriasis | 12/2021 | OTEZLA · p.9 |
| Recent Major Changes - Warnings and Precautions, Hypersensitivity | 12/2021 | OTEZLA · p.9 |
| Depression or depressed mood incidence | 1.0 % | OTEZLA (Psoriatic Arthritis) · p.11 |
| Depression or depressed mood incidence | 0.8 % | Placebo (Psoriatic Arthritis) · p.11 |
| Abdominal pain incidence | 2 % | Placebo (Moderate to Severe Plaque Psoriasis) · p.14 |
| Serious depression | 0.2 % | OTEZLA (Psoriatic Arthritis) · p.11 |
Source: Amgen Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →