Regeneron/ Sanofi granted FDA label expansion for Dupixent in COPD Sep. 27, 2024 1:16 PM ET By: Dulan Lokuwithana , SA News Editor [Seeking Alpha]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: Seeking Alpha
FDA approved a label expansion for its asthma therapy Dupixent (dupilumab) for certain patients with chronic obstructive pulmonary disease (COPD), a respiratory disorder. With its latest approval, the inflammatory disease therapy, already approved in the U.S. for conditions such as atopic dermatitis, will also be indicated as an add-on maintenance treatment for certain adults with uncontrolled COPD. Previously, the FDA delayed its action on the duo's supplemental biologics license application ((sBLA)), which was expected to receive approval by June 27, 2024. In May, the agency extended the action date by three months to Sept. 27 after determining that the additional data the companies submitted following a regulatory request constituted a major amendment to the sBLA. The approval is backed by Regeneron's ( REGN ) and Sanofi's ( SNY ) pivotal phase 3 studies, BOREAS and NOTUS, which reached the primary endpoint, indicating a 30% and 34% reduction in moderate or severe COPD even
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News
- FDA greenlights Regeneron's Dupixent for the treatment of COPD [Yahoo! Finance]Yahoo! Finance
- Sanofi/Regeneron's Dupixent set to dominate COPD biologics market following FDA approval [Yahoo! Finance]Yahoo! Finance
- Press Release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPD [Yahoo! Finance]Yahoo! Finance
- Press Release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPDGlobeNewswire
- Press Release: Dupixent approved in China as the first-ever biologic medicine for patients with COPDGlobeNewswire
SNY
Sec Filings
- 9/24/24 - Form 6-K
- 9/13/24 - Form 6-K
- 9/3/24 - Form 6-K
- SNY's page on the SEC website