FDA Approves Expanded Use of Jazz Pharma’s Sleep Disorder Drug Xywav

Jazz Pharmaceuticals PLC said on Thursday its sleep disorder drug Xywav received 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 percent to $146.66 in the afternoon session. The 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 …

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