Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Regeneron Says FDA Seeks More Data, Information For ARCALYST SBLA

RELATED NEWS
Trade REGN now with 

Regeneron Pharmaceuticals, Inc. (REGN: Quote) 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.

Click here to receive FREE breaking news email alerts for Regeneron Pharmaceuticals and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
New Zealand's diary giant Fonterra lowered its forecast for farmer payouts for the 2014/15 season citing falling world dairy prices and a strong New Zealand dollar. The 2014/15 Farmgate Milk Price forecast was lowered to NZ$6 per kg of milk solids from its earlier estimate of NZ$7 per kg in May, the... Home improvement and building products company Masco Corp. said Monday after the markets closed that its second quarter profit jumped 78% from last year, as revenue increased and margins improved amid strong performance of its Plumbing Products, Installation and Other Services and Decorative Architectural Products segments. American Financial Group Inc. (AFG) Monday reported second-quarter net earnings of $106 million or $1.15 per share, compared to $110 million or $1.20 per share last year. Core net operating earnings were $99 million or $1.07 per share, compared to $87 million or $0.96 per share last year. Total...
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.