Celgene’s Otezla OK’d in plaque psoriasis
This article was originally published in Scrip
The FDA on 23 September gave Celgene the go-ahead to market Otezla (apremilast), a selective inhibitor of phosphodiesterase 4 (PDE4), to treat moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
The drug is the first and only PDE4 inhibitor approved in plaque psoriasis, a chronic inflammatory disease of the skin, which results from an uncontrolled immune response.
The condition affects more than 125 million people worldwide.
Otezla gained the FDA's initial blessing in March as the first oral therapy in the US to treat adults with active psoriatic arthritis (scripintelligence.com, 21 March 2014).
In clinical trials, Otezla reduced redness, thickness and scaliness of plaques in patients with moderate or severe plaque psoriasis, noted Dr Shane Chapman, the dermatology section chief at Dartmouth-Hitchcock Medical Center.
"Because the product labeling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience," he said.
Otezla's approval in plaque psoriasis was based primarily on safety and efficacy results from two multicenter, randomized, double-blind, placebo-controlled studies – ESTEEM 1 and ESTEEM 2, in which treatment resulted in significant and clinically meaningful improvements, Celgene reported.
Shares of Celgene closed at $93.12 on 23 September, up 92 cents, or about 1%.