September 24, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Biopharma behemoth Celgene Corporation announced today that it has received approval from the U.S. Food and Drug Administration for Otezla, an oral selective inhibitor ofphosphodiesterase 4 for patients who have moderate to severe plaque psoriasis.
Currently, Otezla is the first and only PDE4 inhibitor approved for the treatment of this condition. Psoriasis affects more than 125 million people around the world.
“Otezla offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments,” said M. Shane Chapman, section chief of dermatology at Dartmouth-Hitchcock Medical Center. “In clinical trials, Otezla reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis. 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.”
The FDA approved Otezla after receiving the results on safety and efficacy from two multi-center, randomized,double-blind, placebo-controlled studies. These studies, titled Esteem 1 and Esteem 2, were conducted in adult patients who had moderate to severe plaque psoriasis. Otezla showed that it could provide significant improvements in plaque psoriasis as measured by Psoriasis Area and Severity Index scores in week 16.
About 1,426 patients were examined in three clinical trials. Side effects of the drug included diarrhea, nausea, tension and headache.
“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,” said Scott Smith, president of inflammation and immunology for New Jersey-based Celgene.
Otezla is available in the U.S. and dispensed through a wide number of specialty pharmacies. It was approved for the treatment of adults with active psoriatic arthritis on March 21, 2014.
“Psoriasis is a serious autoimmune disorder commonly associated with comorbidities,” said Randy Beranek, president and chief executive of the National Psoriasis Foundation. “Effectively treating psoriasis is an important part of managing a patient’s overall health. Having a new treatment like Otezla is important so patients can have more options and can work closely with their providers to find what works best for them.”
