U.S. FDA rejects expanded indication for Regenron's gout drug
July 30 |
July 30 (Reuters) - U.S health regulators have denied approval to Regeneron Pharmaceuticals Inc's experimental drug to prevent gout flares, dashing the hopes of the company of expanding usage of the drug that is already on the market for another indication.
The agency requested additional clinical data, including additional chemistry, manufacturing and controls information related to a proposed new dosage form for the drug, Arcalyst, Regeneron said in a statement.
The drug is approved to treat a group of rare genetic auto-inflammatory diseases. Regeneron said it was reviewing the FDA's requests and will determine the appropriate next steps accordingly.
The New York-based company's shares closed at $135.47 on Monday on the Nasdaq.
- Tweet this
- Share this
- Digg this