FDA Approves Apremilast for Plaque Psoriasis

September 24, 2014

The FDA has approved the PDE4 inhibitor apremilast (Otezla) for plaque psoriasis. It was already approved for psoriatic arthritis.

Celgene Corporation has approval by the US Food andDrug Administration of its novel anti-inflammatory apremilast (Otezla) for treatment of moderate to severe plaque psoriasis eligible for systemic treatment or phototherapy.

Approved last March for psoriatic arthritis, apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic AMP. The inhibition appears to modulate the production of inflammatory mediators, although the mechanism is not well defined.

Approval for pslaque psoriasis was based on two phase III randomized, placebo-controlled trials, ESTEEM1and
ESTEEM2, involving about 1,250 patients. Treatment with apremilast achieved significant improvements in plaque psoriasis as measured by Psoriasis Area and Severity Index (PASI) scores at week 16.