Celgene Wins U.S. Approval of New Psoriasis Pill

Celgene Corp. (CELG) won U.S. approval for its drug to treat the skin disease psoriasis, a medicine that will compete with injections that now generate billions of dollars in sales each year.

The Food and Drug Administration cleared Otezla for people with moderate to severe psoriasis, Celgene said today in a statement. Psoriasis is the most common autoimmune disease in the U.S., affecting 7.5 million Americans, according to the National Psoriasis Foundation. The agency in March authorized the treatment, also known as apremilast, to combat a related condition.

Psoriasis causes raised, red, scaly patches on the skin. Its commonly treated with injections, including AbbVie Inc. (ABBV)s Humira, and Enbrel from Amgen Inc. (AMGN) and Pfizer Inc. (PFE) Otezla is expected to generate $1.03 billion in sales in 2017, according to the average of 11 analysts estimates compiled by Bloomberg.

Otezla offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments, M. Shane Chapman, section chief of dermatology at Dartmouth-Hitchcock Medical Center, said in the statement. 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.

Celgene, the Summit, New Jersey-based maker of the cancer drug Revlimid, rose 1 percent to $93.12 at the close in New York. The companys shares have gained 27 percent in the past 12 months.

The FDA approved Otezla this year to treat psoriatic arthritis, which causes painful, stiff and swollen joints and occurs in about 30 percent of people who suffer from psoriasis. The drug is associated with an increased risk of depression. Common side effects include diarrhea, headache and nausea.

Celgene is studying Otezla for use against other diseases as well, including rheumatoid arthritis and another form of arthritis that can lead to a new bone formation on the spine, called ankylosing spondylitis. The company said in June the drug failed to significantly help patients in a trial with ankylosing spondylitis.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Drew Armstrong, Andrew Pollack

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Celgene Wins U.S. Approval of New Psoriasis Pill