Celgene Wins U.S. Approval for Psoriatic Arthritis Pill
Celgene Corp. (CELG), the maker of the cancer drug Revlimid, won U.S. approval of a pill to treat psoriatic arthritis that may challenge injections that are among the best-selling drugs on the market.
The medicine, called Otezla, was cleared to treat arthritis associated with the skin condition psoriasis, the Food and Drug Administration said today in a statement, giving the company its first victory in its effort to sell the drug for a handful of other inflammatory diseases. The painful joint condition occurs in about 30 percent of the 125 million people worldwide who have psoriasis, according to Summit, New Jersey-based Celgene.
The drug, also known as apremilast, is an oral medication while commonly used treatments are given by injection, including AbbVie Inc. (ABBV)’s Humira and Enbrel, from Amgen Inc. (AMGN) and Pfizer Inc. (PFE) Humira generated $10.7 billion in 2013 while Amgen and Pfizer reported $8.32 billion in Enbrel sales. Otezla may produce $1.1 billion in sales by 2017, according to the average of 14 analysts’ estimates compiled by Bloomberg.
“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”
The FDA is requiring Celgene to assess the risk of Otezla to pregnant women. The most common side effects reported in clinical trials were diarrhea, nausea and headache, the agency said.
Celgene fell 3.7 percent to $144.40 at the close in New York. The Nasdaq Biotechnology Index of 121 companies including Celgene fell 4.4 percent after Democrats in Congress wrote Gilead Sciences Inc. questioning the pricing of its hepatitis C treatment Sovaldi.
Psoriasis is the most common autoimmune disease in the U.S., affecting as many as 7.5 million Americans, according to the National Psoriasis Foundation. It causes raised, red, scaly patches on the skin, while psoriatic arthritis causes pain, stiffness and swelling in the the joints, the foundation, based in Portland, Oregon, said. Injected treatments can lead to skin reactions at the site where the needle is inserted.
Celgene expects the FDA to rule on its application for Otezla to treat psoriasis in September and is studying the drug in other conditions including rheumatoid arthritis and a form of arthritis that can lead to new bone formation on the spine.
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