Dupixent COPD Approval Could Be Delayed, Regeneron Cautions

 
• By Jessica Merrill
  
Generate a summary of this article
Listen to this article
Beta

The US Food and Drug Administration has requested additional efficacy information on the supplemental filing in the potentially large new indication.

hour glass
Regeneron signaled a possible delay for Dupixent in COPD • Source: Shutterstock

Regeneron Pharmaceuticals, Inc. has many moving parts to prioritize this year as it transitions patients to a new version of its blockbuster ophthalmology drug Eylea (aflibercept), expands the use of Dupixent (dupilumab) to a potentially big new indication in chronic obstructive pulmonary disease (COPD), and advances an interesting pipeline that includes therapies for obesity, cancer, allergy and hearing loss.

CEO Leonard Schleifer cautioned investors during a first quarter sales and earnings call on 2 May that a US Food...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Immunological

Cagrisema Leads The Charge For 2025

 
• By Elizabeth Cairns

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

As More DLL3 Bispecifics Advance, Doctors Are Adjusting To CRS, ICANS

 
• By Mandy Jackson

Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.

Sanofi/Regeneron’s Dupixent: A First For COPD, But Not The Last

 
• By Jessica Merrill

The IL-4/13 inhibitor was approved in the US for COPD, a blockbuster-sized indication, but the commercial ramp could take time and several competitors are on its heels.

Biogen Joins Molecular Glue Degrader Club with Neomorph Pact--Test-1

 
• By Saba Afreen

As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.

More from Therapeutic Category

Scrip Data Article Without An Author

"Neque porro quisquam est qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit..."

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.