1. Scrip
  2. >>Business
  3. >>Strategy

Jazz Phase III Success With Xywav In Idiopathic Hypersomnia Strengthens A Valuable Franchise

 
• By Jessica Merrill

The company plans to file for approval in the expanded indication, for which there are currently no approved therapies.

pretty woman waking up and yawning
Jazz is building out its sleep disorder franchise • Source: Shutterstock

Jazz Pharmaceuticals plc has reached an important catalyst with positive Phase III data on Xywav (calcium/magnesium/potassium/sodium oxybates) in a potential new indication for idiopathic hypersomnia (IH), a form of excessive daytime sleepiness that could extend the life of its blockbuster narcolepsy franchise.

The company announced positive data on 8 October from a Phase III double-blind, placebo-controlled trial evaluating the efficacy and safety of Xywav oral solution in the new indication. Jazz said it plans to file a supplemental New Drug Application with the US Food and Drug Administration in the first quarter of 2021

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 Strategy

Will Other Major MASH Deals Follow GSK/Boston Pharma?

 
• By Joseph Haas

GSK’s $1.2bn payout for Boston Pharma’s efimosfermin is the first billion-dollar-plus MASH deal in nearly nine years, but several other advanced MASH programs could be positioned for takeout.

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

AbbVie On MFN: ‘We Have To Take It Seriously’

 
• By Jessica Merrill

AbbVie chief commercial officer Jeffrey Stewart called Trump’s drug pricing plan a “disruption” but said ultimately the delta between US and EU drug prices may not be as high as some expect.

More from Business

Merck KGaA Braces For Volatility But Does Not Expect Europe To Budge On Pricing

 
• By Andrew McConaghie

Shares are hit as German conglomerate lowers revenue forecast.

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.