Sanofi/Regeneron's Dupixent set to dominate COPD biologics market following FDA approval [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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Source: Yahoo! Finance
The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron's interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market. The asset is tailored towards patients with moderate-to-severe exacerbations with chronic obstructive pulmonary disease (COPD), as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an inhaled corticosteroid, a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or a combination of a LABA and a LAMA. Dupixent has gained great traction and positive opinions from key opinion leaders (KOLs) due to the successful and consistent data presented from the asset's two Phase III clinical trials, named NOTUS and BOREAS, as well as the large presence of Sanofi and Regeneron at the 2024 European Respiratory Society (ERS) Congress in Vienna, Austria, earlier in September. Dupixent's approval is set to improve the treatment landscape
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News
- FDA greenlights Regeneron's Dupixent for the treatment of COPD [Yahoo! Finance]Yahoo! Finance
- 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
- 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