1. Scrip
  2. >>New Products

Zuranolone Launch Requires Sage To Shift The Way Doctors Treat Depression

US Approval Decision Expected By 5 August

 
• By Mandy Jackson

CEO Barry Greene and team spoke with Scrip about Sage and Biogen’s focus on short-term, episodic dosing, and said doctors and payers – pending zuranolone’s approval – are responding to the sales pitch.  

Panic attack in public place; depressed sad person surrounded by people walking in busy street.
Zuranolone has shown efficacy in depressed patients who also have anxiety • Source: Shutterstock

The clinical trials are completed, a new drug application has been accepted, and the US Food and Drug Administration has set a 5 August action date for deciding whether to approve Sage Therapeutics, Inc.’s zuranolone for major depressive disorder (MDD) and postpartum depression (PPD). And while checking those tasks off its to-do list with partner Biogen, Inc., the companies have been working on a commercial strategy they are eager to roll out around the end of the year that will require a new way of thinking about how to treat depression.

Even with a summertime approval, if all goes to plan, it will be late 2023 before zuranolone is available for...

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 New Products

Pipeline Watch: ASCO Dominates 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.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By Andy Smith

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

More from Scrip

Stock Watch: On Q1 Vaccine Sales And Measles Outbreaks

 
• By Andy Smith

A recent study suggested that measles could become endemic in the US due to low vaccination rates. However, first-quarter vaccine sales offered a more nuanced picture.

Merck & Co.’s RSV Antibody Approved In US In Time To Compete With Blockbuster Beyfortus

 
• By Mandy Jackson

The US FDA approved Merck’s Enflonsia (clesrovimab) to prevent RSV in newborns and infants on the same day Sanofi assured that it would ship Beyfortus in time for the 2025-2026 RSV season.

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.