FDA greenlights Regeneron's Dupixent for the treatment of COPD [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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Source: Yahoo! Finance
Pharmaceuticals and Sanofi have expanded the US label of Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD). The approval makes COPD the sixth indication for the blockbuster treatment and makes Dupixent the first available biologic for the condition. As per a 27 September press announcement, Dupixent will be used as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. Current treatment options for COPD include bronchodilators such as beta2-agonists and anticholinergics, standalone or combination inhaled corticosteroids (ICS), and other combination medications. While these therapies are tolerated by patients, GlobalData's analysts note that the progressive nature of COPD necessitates the development of maintenance therapies in addition to standard of care. Dupixent's approval in COPD comes after GSK's anti-IL-5 antibody Nucala (mepolizumab) failed to pass muster with the regulator . AstraZeneca's anti-
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News
- 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]Seeking Alpha
- 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
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- 9/3/24 - Form 6-K
- SNY's page on the SEC website