FDA approves Otezla for plaque psoriasis

The Food and Drug Administration has approved apremilast (Otezla, Celgene) for the treatment of adult patients with moderate-to-severe plaque psoriasis, the second approval for the drug this year.

Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4) is the first PDE4 inhibitor approved for plaque psoriasis, according to a news release. The drug indicated for patients for whom systemic therapies or phototherapy is appropriate.

Apremilast was tested in two multicenter, randomized, double-blind, placebo-controlled studies. About 1,250 patients with moderate-to-severe plaque psoriasis were randomized 2:1 to receive apremilast 30 mg twice daily or placebo for the first 16 weeks, then a maintenance phase from weeks 16 to 32 during which patients receiving placebo were instead given apremilast 30 mg twice daily through week 32. Then there was a randomized withdrawal phase for responders from weeks 32 to 52 based on initial Otezla randomization and PASI-75 response.

Treatment with Otezla demonstrated “significant and clinically meaningful improvements” in plaque psoriasis when measured by PASI scores at week 16, according to the company.

“Otezla offers a valuable treatment option for a spectrum of plaque psoriasis patients - patients who are treatment-naïve as well as patients who are treatment-experienced, including those previously treated with biologic agents or conventional systemic agents,” Scott Smith, president of Inflammation & Immunology at Celgene, said in a statement.

The FDA approved Otezla in March 2014 for the treatment of adult patients with psoriatic arthritis.