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

Quick Facts

Editors Pick
Saudi Arabia is reportedly considering to list its state-run oil behemoth Saudi Aramco in New York Stock Exchange. According to a WSJ report, citing people familiar with the matter, Aramco prefers to float its shares on the NYSE, or in London or Toronto after discussion to list on an Asian stock exchange... Anglo-Australian mining giant BHP Billiton plc reported Tuesday a profit in its first half, compared to last year's hefty loss on sharply lower one charges. Underlying EBITDA, a key earnings metric, climbed 65 percent with higher production and prices. The company further lifted its dividend by 150 percent. Shares of HSBC Holdings Plc declined around 4 percent in Hong Kong trading after the Asia-focused lender reported wider net loss in its fourth quarter amid weak net interest income. Further, the company maintained its dividend, and said its Board plans a further $1.0 billion share buy-back, which is expected to complete in the first half of 2017.
comments powered by Disqus
Follow RTT