logo
Share SHARE
FONT-SIZE Plus   Neg

Regeneron Says FDA Seeks More Data, Information For ARCALYST SBLA

Regeneron Pharmaceuticals, Inc. (REGN) said Monday that the U.S. Food and Drug Administration issued a Complete Response Letter for the supplemental biologics license application for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.

The Complete Response Letter states that the FDA cannot approve the application in its current form. The agency has requested additional clinical data, as well as additional chemistry, manufacturing, and controls information related to a proposed new dosage form.

Regeneron said it is reviewing the Complete Response Letter and that it will determine appropriate next steps.

The FDA's action does not impact the approved indication of ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes, including Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome in adults and children 12 and older.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
French oil and gas giant Total SA (TTA.L, TTFNF.PK, TOT) reported Wednesday a profit for the second quarter that declined four percent from last year, reflecting a sales decline amid sharply lower oil prices. However, hydrocarbon production grew 12 percent from last year. The company's results were... Procter & Gamble Co., (PG) Tuesday announced the promotion of David Taylor to the role of Chief Executive Officer, as the consumer goods giant replaces Chief Executive A.G. Lafley for the second time. David Taylor, a 35-year-veteran and currently Group President of Global Beauty, Grooming and Health... Anadarko Petroleum reported a plunge in second-quarter profit, hurt by weak oil prices, partly offset by some derivative gains. However, its earnings topped Street estimates, driven by operational efficiencies and sales of higher-margin oil. Anadarko shares...
comments powered by Disqus
Follow RTT