FDA Approves New Indication for Celgene’s Psoriasis Drug Otezla

September 29, 2014

Celgene’s psoriasis drug Otezla will soon be available to a new group of patients following the FDA’s recent approval of an extended indication.

The new indication covers treatment-experienced and treatment-naïve patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy are appropriate. The decision was based on results of two trials that showed that Otezla (apremilast) reduced redness, thickness and scaliness of plaques.

In both studies, Otezla was able to clear or nearly clear some patients’ skin, Celgene says. This is fairly comparable to a lot of the available biologics indicated for psoriasis, Celgene spokeswoman Cathy Cantone said. Otezla, however, has two significant advantages over existing products, she said.

One is that Otezla is a pill that patients can take twice a day from anywhere, compared with many other available therapies that involve infusions or injections administered in an office over a period of time. The other is that Otezla doesn’t require initial screening and later monitoring for infections such as tuberculosis, as many other psoriasis therapies do, Cantone said.

Psoriasis is a disorder in which patients’ own immune systems attack the skin, causing thick, red scales. Some patients have just a few small patches, while other patients have scales all over their bodies. Otezla works by inhibiting phosphodiesterase 4, which is thought to control inflammation.

Otezla was approved for psoriatic arthritis in March. Celgene is waiting on decisions from Health Canada regarding Otezla’s suitability for psoriasis, and from the European Medicines Agency regarding both psoriasis and psoriatic arthritis. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.