Regeneron, Sanofi Get Speedy FDA Review of Dupixent in COPD
By Colin Kellaher
Regeneron Pharmaceuticals and Sanofi have won U.S. Food and Drug Administration priority review for their application seeking expanded approval of Dupixent in chronic obstructive pulmonary disease, potentially adding a sixth U.S. indication for their blockbuster anti-inflammatory drug.
Regeneron and Sanofi on Friday said the application covers Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease, or COPD.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. The agency has set a target action date of June 27 for the application.
Regeneron and Sanofi said an FDA green light would make Dupixent the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decade.
Regulatory submissions also are under review in China and Europe, the companies said.
Tarrytown, N.Y., biotechnology company Regeneron created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement, while Sanofi markets the product internationally. The drug generated roughly $11.6 billion in sales last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 23, 2024 06:15 ET (11:15 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
How Anti-Obesity Drugs Are Innovating the Healthcare Market
-
What’s Happening In the Markets This Week
-
Why Immigration Has Boosted Job Gains and the Economy
-
What to Invest in During High Inflation
-
Never Mind Market Efficiency: Are the Markets Sensible?
-
Starbucks Stock Could Use a Pick-Me-Up After Big Selloff; Is it a Buy?
-
5 Cheap Stocks to Buy From an Attractive Part of the Market
-
Markets Brief: All Eyes On Inflation
-
After Earnings, Is Lyft Stock a Buy, a Sell, or Fairly Valued?
-
8 Stock Picks in the Apparel Industry
-
Baidu Earnings: Advertising Weakness Offset by Continued Growth In Cloud Business
-
Going Into Earnings, Is Target Stock a Buy, a Sell, or Fairly Valued?
-
Walmart Earnings: Low Prices and Strong Digital Presence Drive Market Share Gains
-
After Earnings and a Big Selloff, Is Shopify Stock a Buy, a Sell, or Fairly Valued?
-
Cisco Earnings: Positive Guidance and Splunk Inclusion Align With Our Long-Term Thesis
-
3 Warren Buffett Stocks to Buy After Berkshire Hathaway’s Just-Released 13F Filing