1. Scrip
  2. >>Therapy Areas
  3. >>Neurological

Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval

 
• By Mandy Jackson

After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space.

SAGE Therapeutics Inc. will get at least three more months to prepare for the US launch of Zulresso (brexanolone) now that the US FDA has extended the user fee date for its new drug application after the company submitted a proposed risk evaluation and mitigation strategy (REMs) program for the intravenously administered postpartum depression (PPD) drug.

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

GSK Ramps Up Neuroscience Investment With ABL Brain Shuttle Deal

 
• By Andrew McConaghie

The pact could be worth more than $2.6bn and adds to growing big pharma investment in the technology.

Roche’s Brain Shuttle Delivers In Alzheimer’s, Moves Ahead To Phase III

 
• By Andrew McConaghie

By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.

Axsome Plans Excessive Sleepiness Study In Depression After Phase III Failure

 
• By Alaric DeArment

The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.

Cerevance To Focus On Parkinson’s Adjunctive Therapy After Phase II Miss

 
• By Joseph Haas

After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.

More from Therapy Areas

Ferring’s Faith In Bladder Cancer Gene Therapy Starts To Pay Off

 
• By Kevin Grogan

Adstiladrin sales hit €70m in first full year on the market

Multiple Tactics Likely Needed To Control Obesity Drug Costs

 
• By Alaric DeArment

ICER’s new white paper pointed to estimates that the GLP-1 drugs may result in more than $100bn in annual spending, highlighting the need to rein in costs.

Cartesian Maps Out CAR-T Strategy With Simpler Logistics In Mind

 
• By Alaric DeArment

The company announced positive Phase IIb data for Descartes-08 in myasthenia gravis, with especially strong efficacy among patients without prior biologic treatment.