UPDATE 1-US FDA expands approval for Avadel's sleep disorder drug

Reuters10-17

(Adds background in paragraph 3, 4, share movement in paragraph 5)

Oct 17 - The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.

Shares of Avadel rose 3.5% to $13.70 in early morning trade.

The company said on Thursday the drug, called Lumryz, was now approved to treat pediatric patients with sudden muscle weakness called cataplexy or for excessive daytime sleepiness (EDS), both symptoms of narcolepsy. It was approved for adults in 2023.

Narcolepsy is a chronic neurological disorder that impacts the brain's ability to regulate sleep and wake cycles, with 70% of patients also experiencing cataplexy.

Dosed once a night, Lumryz competes with twice-nightly drugs such as Jazz Pharmaceuticals' Xyrem and Xywav.

(Reporting by Unnamalai L and Christy Santhosh in Bengaluru; Editing by Devika Syamnath)

((Unnamalai.L@thomsonreuters.com;))

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment