The FDA has approved Otezla (apremilast; Celgene) tablets for the treatment of adults with active psoriatic arthritis. Otezla is a phosphodiesterase-4 (PDE-4) inhibitor that intracellularly modulates a network of pro-inflammatory and anti-inflammatory mediators.
Safety and efficacy of Otezla was studied in 3 clinical trials evaluating over 1,493 patients with active psoriatic arthritis. Treatment with Otezla resulted in improvement of signs and symptoms of psoriatic arthritis, including tender and swollen joints and physical function, compared to placebo.
The FDA is requiring a pregnancy exposure registry as part of a post-marketing requirement to assess risks to pregnant women.
Otezla will be available in 60-count bottles (30mg tablets), a 13-tablet blister titration pack (10mg, 20mg, 30mg tablets), and two 14-count blister cards (30mg tablets). The product is expected to be available in March 2014 through a network of specialty pharmacies.
For more information call (888) 771-0141 or visit Otezla.com.