U.S. health regulators have already approved Celgene Corporation's oral drug Otezla in March this year as treatment for people with psoriatic arthritis (PsA), a type of arthritic inflammation that affects about 15 percent of people who have the immune-mediated skin disease psoriasis.
Individuals who suffer from moderate to severe plaque psoriasis, however, can now use the drug, also known chemically as apremilast, as it has yet again gotten the approval of the U.S. Food and Drug Administration (FDA) as treatment for plaque psoriasis, the most common form of psoriasis characterized by raised patches and reddish skin with silvery-white scales that are commonly found in the elbows, knees, lower back, and scalp.
"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 Celgene Corporation's Global Inflammation and Immunology President Scott Smith.
About 125 million individuals worldwide have psoriasis. In the U.S., the condition affects about 7.5 million people making it the most common autoimmune disease in the country. About 80 percent of these individuals have plaque psoriasis.
The approval was based on the safety and efficacy results of randomized and placebo-controlled ESTEEM 1 and ESTEEM 2 studies, which involved adult PsA patients, who exhibited clinically significant improvements in their condition based on Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA) scores.
Mark Lebwohl, from the department of dermatology of the Icahn School of Medicine at Mount Sinai in New York said that several injectable drugs for psoriasis were introduced in recent years and Celgene's drug made it as the first oral drug to be green-lighted as treatment for psoriasis in a long time.
"Apremilast is the first oral drug approved for psoriasis in decades," Lebwohl said. "This adds a safe, useful therapeutic option for patients with this debilitating condition."
Common side effects associated with use of the drug that were observed in clinical trials include nausea, diarrhea, upper respiratory tract infection and headache, which occurred during the first weeks of treatment but appear to lessen with continued use of Otezla. The drug is also linked with increased risks for depression so patients starting on the drug are advised to inform their doctors if they have suicidal behaviors or a history of depression.
Celgene is also studying Otezla for use in treating other diseases including rheumatoid arthritis and ankylosing spondylitis.
