1. Scrip

Alkermes Expects Gradual Ramp-Up For Lybalvi Launch

 
• By Joseph Haas

Alkermes’ combo pill of olanzapine and samidorphan gets US FDA approval; company predicts $10m first-year sales as schizophrenia/bipolar patients cycle through treatment options, including generics.

Brain scan
Alkermes hopes to slowly build market for new schizophrenia/bipolar therapy

Alkermes plc is preparing to launch Lybalvi (olanzapine/samidorphan) in the fourth quarter as a new treatment option for schizophrenia and bipolar I disorder with less weight gain than traditional olanzapine, and the company is guiding investors to expect a gradual ramp up as patients cycle through the various treatment options already available, including generics.

Lybalvi (previously ALKS 3831) cleared the US Food and Drug Administration 1 June for treatment of schizophrenia in adults as...

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

More from Scrip

Top 10 Drugs Q1 2025: Keytruda Dominates; Mounjaro Climbs

 
• By Eleanor Malone

Lilly’s Mounjaro for diabetes rose from sixth to third position among the top-selling drugs in the first quarter of 2025, Rival Ozempic retained second position and Merck & Co’s immuno-oncology blockbuster Keytruda stayed far ahead.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By Kevin Grogan

Oral RNA splicing modulator has gone into a Phase II/III trial

BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.