Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB17 hours ago · The health regulator has cleared the drug's use as an add-on treatment for some adults with inadequately controlled chronic obstructive pulmonary disease (COPD), a condition that progressively ...
Dupixent® (dupilumab) Approved in the U.S. as the First-ever …
WEB17 hours ago · 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. Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung ...
FDA signs off on Regeneron and Sanofi's Dupixent for COPD
WEB17 hours ago · After more than a decade without any therapeutic advancements in chronic obstructive pulmonary disorder (COPD), people with the progressive disease suddenly have two new options, with more likely ...
Dupixent® (dupilumab) Approved in China as the First-ever …
WEBTARRYTOWN, N.Y. and PARIS, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that 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 ...
FDA, after delay, clears Regeneron and Sanofi drug for COPD
WEB1 day ago · European regulators approved Dupixent for COPD in July, but Regeneron and Sanofi have had to wait longer in the U.S., where the FDA requested additional efficacy data from the two trials. Over that time, a potential new competitor has emerged in GSK’s Nucala, which the FDA rejected in 2018 but earlier this month succeeded in a Phase 3 trial.
Regeneron, Sanofi Get FDA OK for Dupixent to Treat COPD
WEB1 day ago · Green light covers Dupixent as an add-on maintenance treatment in certain adults with uncontrolled chronic obstructive pulmonary disease, or COPD. Regeneron REGN 1.83%increase; green up pointing ...
INVESTORS & MEDIA - Regeneron Pharmaceuticals Inc.
WEBMay 31, 2024 · The primary endpoint was met in both trials, showing Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34%, compared to placebo. Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
INVESTORS & MEDIA - Regeneron Pharmaceuticals Inc.
WEBNov 27, 2023 · Regeneron and Sanofi are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab.
Sanofi/Regeneron’s Dupixent set to dominate COPD biologics …
WEB14 hours ago · 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 ...
Regeneron, Sanofi's Dupixent Get FDA Approval For Chronic Obstructive ...
WEB16 hours ago · Regeneron, Sanofi Say Dupixent Approved In China To Treat Chronic Obstructive Pulmonary Disease RTTNews 3h Press Release: Dupixent approved in China as the first-ever biologic medicine for ...