US FDA expands use of Avadel's sleep disorder drug to ages 7 and up

Reuters

US FDA expands use of Avadel's sleep disorder drug to ages 7 and up

1:59 chiều giờ GMT, 17 Tháng 10 2024

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Adds analyst comment in paragraph 4, analyst estimates in paragraph 6 and details on Jazz and Avadel's drugs throughout

By Unnamalai L and Christy Santhosh

Oct 17 -The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' AVDL.O sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for popular treatmentsfrom Jazz Pharmaceuticals.

Avadel saidon 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.

Lumryz's main area of differentiation from Jazz Pharma's JAZZ.O Xyrem and Xywav is its once-nightly dosing that eliminatesthe need to wake up in the middle of the night, Needham analyst Ami Fadia said.

Avadel's drug containsa central nervous system depressant drug called sodium oxybate, which helps increase the amount of time someone spends in deep sleep. Children make up about 5% of the current oxybate-treated population.

Jefferies expects peak annual salesof $550 million to $1 billion from Lumryz, with the pediatric approval expected to add another $50 to $100 million.

While Jazz'ssleep disorder drugs are approved for the same condition as Lumryz, Xywavhas the FDA's expanded nod to treat idiopathic hypersomnia, a rare neurological condition that causesexcessive sleepiness.

Last year, Jazz brought in $569.7 million in Xyrem sales and $1.27 billion from Xywav. Lumryz, launched over a year ago, brought about $28 million for Avadel.

Lumryz comes with a boxed warning for reduced stimulation of the central nervous system, and for its potential for abuse and misuse.

Shares of Avadel rose 1.4% to $13.43 in morning trade.

The FDA's decision on Lumryz was expected in September, but it was extended after the health regulator said the drug was stillunder review.

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

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