OTEZLA
LaunchNDAORALTABLET
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
OTEZLA by Amgen is 4 (pde4) specific for cyclic adenosine monophosphate (camp). Approved for older, weighing at least 20 kg with active psoriatic arthritis, weighing at least 50 kg with active psoriatic arthritis and 3 more indications. First approved in 2025.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTEZLA (apremilast) is an oral small-molecule PDE4 inhibitor that increases intracellular cAMP levels to modulate immune and inflammatory responses. It is indicated for adults and pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis. The exact mechanism by which apremilast achieves its therapeutic effects remains incompletely understood despite its well-defined molecular target.
$0.364MPart D
Launch15.9 years to LOEEarly-stage commercial launch by Amgen with minimal current Medicare utilization suggests aggressive market access and field team expansion opportunities ahead.
Mechanism of Action
4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.
Indications (6)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.