July 30 Regeneron Pharmaceuticals Inc
said U.S. regulators have denied approval for it to expand use
of its Arcalyst drug to prevent gout flares, asking that the
company provide more clinical data.
The rejection follows a unanimous vote against the drug's
approval in early May by advisors to the U.S. Food and Drug
Administration, with panel members expressing concern that the
company had only done a 16-week study.
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
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
New York-based Regeneron's shares closed at $135.47 on
Monday on the Nasdaq.