1. Scrip
  2. >>Therapy Areas

Sage/Biogen Delay Zuranolone Filing, Commercial Path Remains Unclear

 
• By Alaric DeArment

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

DEPRESSION miserable depressed , Depression and its consequences, Depressed emotions concept , alone in depression - Image
Sage/Biogen provided a clear path to approval for zuranolone, though it pushed out their NDA filing to 2H22 • Source: Shutterstock

Sage Therapeutics, Inc. and Biogen, Inc. have again pushed out their filing plans for the antidepressant zuranolone, but their plan provides a clearer – albeit slightly riskier – path to market than before.

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
Start Free Trial

Already a subscriber?

More from Neurological

More from Therapy Areas

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 
• By Alaric DeArment

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
• By Kevin Grogan

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.