The agency has requested additional clinical data, including chemistry, manufacturing and controls information related to a proposed new dosage form for the injectable drug, Arcalyst, Regeneron said in a statement.
Regeneron, which had pitched Arcalyst for approval to treat gout flares in patients starting uric acid-lowering therapy, said it was reviewing the FDA’s requests.
Patients afflicted with gout experience severe pain and inflammation due to deposits of uric acid — a body waste product — in the joints and soft tissues.
Known generically as rilonacept, Arcalyst is already on the market to treat a group of rare genetic auto-inflammatory diseases. It only contributes modestly to Regeneron’s overall sales.
Regeneron is better known for its recently approved Eylea to treat macular degeneration, the leading cause of blindness in the elderly. Arcalyst brought in sales of $6 million in the April-June period, while Eylea’s sales shot up 57 percent to $194 million.
New York-based Regeneron’s shares closed at $135.47 on Monday on the Nasdaq.
(Reporting by Zeba Siddiqui in Bangalore and by Ransdell Pierson in New York; Editing by Andre Grenon and Edwina Gibbs)
http://reut.rs/MguwCk
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