Regeneron, Sanofi Get Speedy FDA Review of Dupixent in Younger CRSwNP Group
By Colin Kellaher
Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration priority review of their application seeking expanded approval of their blockbuster anti-inflammatory drug Dupixent for adolescents with a sinus condition that can lead to a loss of the sense of smell.
Regeneron and Sanofi on Monday said the application covers Dupixent as an add-on maintenance treatment for patients ages 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyposis, or CRSwNP.
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 Sept. 15 for the application.
Regeneron and Sanofi said an FDA green light would make Dupixent the first treatment in the U.S. for those ages 12 to 17 with inadequately controlled CRSwNP, which is driven in part by an underlying type 2 inflammation that obstructs the sinuses and nasal passages. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease isn't adequately controlled.
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
May 13, 2024 06:24 ET (10:24 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
What’s Happening in the Markets This Week
-
Worst-Performing Stock ETFs of the Quarter
-
Q3 in Review and Q4 2024 Market Outlook
-
Top-Performing Stock ETFs of the Quarter
-
September Jobs Report Forecasts Show Moderate Hiring Gains
-
Port Strike a Headache for Shippers but a Potential Tailwind for Certain US Transport Stocks
-
13 Charts on Q3′s Roller-Coaster Rally for Stocks and Bonds
-
5 Stocks to Buy Instead of Overpriced US Equities
-
Consumer Defensives: Despite Angst, Thirsty Investors Have Names to Pursue
-
Industrials: Many Stocks Overvalued After Q3 Outperformance
-
Basic Materials: Despite Index Rise, We See Multiple Long-Term Opportunities
-
What the Election Could Mean for Big Tech Stocks
-
3 Lessons From Recent Stock Market Drama
-
Consumer Cyclicals: Even Amid Moderating Consumer Spending, We See Discounts
-
Healthcare: Valuations Look Fair Overall, With Select Industries Still Undervalued
-
Utilities: Falling Interest Rates, Growth Outlook Boosting Stocks