Dupixent Approved For Severe Asthma With Broader Label Than Other Biologics

The US FDA cleared Sanofi/Regeneron's IL-4/IL-13 inhibitor for moderate-to-severe asthma in patients with an eosinophilic phenotype or with oral corticosteroid-dependent asthma, a broader label than AstraZeneca's Fasenra, GSK's Nucala and Teva's Cinqair.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

Sanofi/Regeneron Pharmaceuticals Inc.'s IL-4/IL-13 inhibitor Dupixent (dupilumab) was approved by the US FDA for a new indication, moderate-to-severe asthma, with a broad label that will make the treatment tough new competition for other biologics approved for severe asthma.

The FDA approved Dupixent Oct. 19 as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
• By 

Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

Pipeline Watch: Ten Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label

 

The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.

Bayer Bags First Global Okay For Hot Flashes Therapy

 
• By 

Lynkuet will compete with Astellas's Veozah/Veoza

More from Scrip

China’s Mid-Cap Companies Thriving On Big Pharma Deals

 

Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.

In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
• By 

Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

Stock Watch: Pharma Financial Forecasts Cannot Withstand Headwinds Forever

 
• By 

Pharma company financial guidance emerged largely unscathed from a first quarter punctured by a weakening US dollar and threats of import tariffs on drugs. With other pressures either already evident or on the horizon, guidance revisions may be unavoidable.