US FDA approves Takeda's sleep disorder pill

Aug 5 (Reuters) - The ‌U.S. Food and ​Drug ​Administration approved Takeda Pharmaceuticals' oral drug for narcolepsy, the health regulator said on Wednesday, backing ‌the first treatment that targets all the symptoms ⁠of the rare sleep disorder.

Here are more details:

• Narcolepsy type 1 ‌is a rare sleep ‌disorder caused by the loss of brain cells that produce orexin, a chemical messenger that regulates wakefulness, sleep, ​and muscle tone.

• The condition – affecting about 120,000 people in the United States, according to Takeda – causes ⁠people to experience excessive daytime sleepiness, sudden loss of muscle tone, cognitive symptoms ​and disrupted nighttime sleep.

• Orzeyful, a twice-daily pill, works by directly targeting the loss of ​orexin signaling that causes the disease.

• ‌The FDA's approval was based on data from two studies in which patients given ⁠Orzeyful showed improvements in their ability to stay awake during the day compared with those given a placebo.

• Previously, there ⁠was no approved medicine for narcolepsy type 1 as a unified disorder, ​and none acted on the orexin system, the FDA said.

• The controlled substance classification for Orzeyful is currently under review by ‌the Drug Enforcement Administration, and their ruling is expected within 90 days, the company ‌said.

• After the classification is determined, the drug will be ⁠made available through a ‌specialty pharmacy to ​U.S. healthcare providers and patients, Takeda added.

(Reporting by Sneha S K in Bengaluru; Editing by Savio ‌D'Souza)

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