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Sanofi and Regeneron's Dupixent becomes the first biologic treatment approved for COPD in the United States.

Shares of Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) edged higher Friday after their chronic obstructive pulmonary disease (COPD) treatment received approval from the Food and Drug Administration (FDA).

On Friday, the FDA approved Regeneron Pharmaceuticals, Inc.  REGN and Sanofi SA's SNY Dupixent (dupilumab) as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, generally known as “smoker's lung.”

The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease commonly known as "smoker's lung", the companies said on Friday.

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype

Dupixent approved in the US as the first-ever biologic medicine for patients with COPD          Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo Dupixent is the leading biologic medicine for all of its FDA-approved indications in new-to-brand prescriptions, and the most prescribed biologic by pulmonologists in the US Paris and Tarrytown, NY, September 27, 2024. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life

Dupixent approved in China as the first-ever biologic medicine for patients with COPD Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function, and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government's Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory and dermatological diseases in China Paris and Tarrytown, New York, Sept. 27, 2024. The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.

TARRYTOWN, N.Y., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2024 financial and operating results on Thursday, October 31, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.