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2021-08-13| Trials & Approvals

Jazz Pharma’s Xywav Becomes First FDA Approved Drug for a Rare Neurologic Disease

by Rajaneesh K. Gopinath
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Dublin-based biopharma Jazz Pharmaceuticals is on a roll notching its second FDA approval in two months. After snagging a win for its blood cancer drug, Rylaze, in June, it has now bagged US approval for Xywav, its sleep disorder drug, for a second indication. 

Xywav is a lower-sodium oxybate first FDA approved in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy. On August 12th, the drug became the first to get approved for treating idiopathic hypersomnia (IH), a rare neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

“Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Eric Bastings, M.D., Deputy Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

“We are excited that with today’s approval, Xywav will become the first and only medicine indicated to treat idiopathic hypersomnia, a unique medical condition that can have significant effects on the lives of those diagnosed with the condition,” said Bruce Cozadd, Chairman, and CEO of Jazz Pharmaceuticals

 

Positive Phase 3 Results

The approval is based on the drug’s strong showing in a Phase 3, double-blind, placebo-controlled withdrawal study conducted in 154 adult patients with IH. Results showed that as compared to placebo, Xywav demonstrated statistically significant and clinically meaningful differences in various standard sleepiness scores, the primary and secondary endpoints of the trial.

“Having an FDA-approved treatment option that manages symptoms associated with idiopathic hypersomnia, including excessive daytime sleepiness and severe sleep inertia, is a significant step forward for patients. Xywav fulfills an unmet need for those diagnosed with this sleep disorder, offering them management of their debilitating symptoms,” said Yves Dauvilliers, M.D., the lead investigator of the study.

The most common adverse events as a result of the treatment observed in the study included nausea, headache, dizziness, insomnia, anxiety, and vomiting. The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. Therefore, the drug comes with a boxed warning for central nervous system depression and abuse, and misuse.

According to Coherent Market Insights, the global IH treatment market is estimated to surpass $429 million by 2027, with an anticipated CAGR of 8.7%. With no competitors in the space, Jazz will be hoping to dominate the IH market for quite some time to come.

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