Healthcare & Pharmaceuticals

U.S. FDA approves expanded use of Jazz Pharma's sleep disorder drug Xywav

3 minute read

Aug 12 (Reuters) - Jazz Pharmaceuticals PLC (JAZZ.O) said on Thursday its sleep disorder drug Xywav received U.S. regulatory approval for the expanded use in patients suffering from excessive daytime sleepiness despite a good night's sleep.

Xywav is currently approved in the United States for the treatment of excessive daytime sleepiness and sudden loss of muscle tone in patients aged seven or older with a neurological disorder called narcolepsy.

Jazz shares rose as much as 1.1% to $146.66 in the afternoon session.

The U.S. Food and Drug Administration's latest decision allows Xywav to be used as a treatment for idiopathic hypersomnia, a chronic sleep disorder with symptoms including excessive daytime sleepiness, difficulty in waking up and longer nighttime sleep.

Jazz said that it plans to make Xywav available to idiopathic hypersomnia (IH) patients later this year.

The drug is expected to bring in sales of $1.49 billion by 2025 end, with $1.1 billion from narcolepsy and around $300 million from IH, Barclays analyst Balaji Prasad said.

There are an estimated 37,000 diagnosed patients currently in the United States with idiopathic hypersomnia and there are currently no approved treatment options for these patients, Jazz Chief Executive Officer Bruce Cozadd said.

Jazz has been attempting to expand its portfolio before the entry of cheaper generic competition for its top-selling drug Xyrem no later than 2023. In May, the drugmaker completed a $7.2 billion acquisition of GW Pharmaceuticals PLC to add a cannabis-based epilepsy treatment to its neuroscience business.

Both Xywav and Xyrem carry a boxed warning flagging risk for potential abuse and misuse and as a central nervous system depressant.

Earlier this month, Jazz said Xywav brought sales of $124.2 million and the number of active Xywav patients grew to 5,100 from 3,900 at the end of the previous quarter.

Reporting by Bhanvi Satija and Manojna Maddipatla in Bengaluru; Editing by Devika Syamnath and Shailesh Kuber

Our Standards: The Thomson Reuters Trust Principles.

More from Reuters