Celgene announced that the Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is the first phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of plaque psoriasis.
The expanded approval was based on safety and efficacy results from 2 multi-center, randomized, double-blind, placebo-controlled studies ESTEEM 1 and ESTEEM 2. Across both studies, treatment with Otezla resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by Psoriasis Area and Severity Index (PASI) scores at Week 16. Also, clinical improvement as measured by static Physician Global Assessment (sPGA) scores of clear to almost clear were also shown in both studies.
Otezla was approved in March 2014 for the treatment of adults with active psoriatic arthritis. Otezla is available in 10mg, 20mg, and 30mg strength tablets.
For more information call (888) 771-0141 or visit Otezla.com.