Jazz Pharmaceuticals Submits Supplemental NDA for Xywav in Idiopathic Hypersomnia
Based on positive phase 3 results in adults with idiopathic hypersomnia, Jazz Pharmaceuticals submitted a supplemental new drug application (NDA) to the FDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution.
Today, Jazz Pharmaceuticals
Pending approval, Xywav would be the only treatment in the United States for patients with the condition.
"This sNDA submission brings us one step closer to making this important treatment option available to patients living with idiopathic hypersomnia,” said Robert Iannone, MD, MSCE, executive vice president of research and development and chief medical officer for Jazz Pharmaceuticals.
The submission is based on
Notably, there were statistically significant worsenings in patients administered a placebo compared with Xywav for ESS (P < .0001), PGIc (P < .0001), and IHSS (P < .0001).
"Our purpose is to innovate to transform the lives of patients, and we are committed to collaborating with regulators, sleep experts, and patients to deepen our understanding of sleep disorders and the science around sleep medicine," said Iannone.
Already
Characterized by chronic and disabling EDS, the prevalence of idiopathic hypersomnia has
Although insurance claims data in the United States indicates that more than 37,000 adult patients have diagnosed idiopathic hypersomnia, Diane Powell, MD, board chair and chief executive officer of the Hypersomnia Foundation, notes that people with the condition often live without an accurate diagnosis for a long time, with some never receiving the diagnosis at all.
“Meanwhile, they struggle to keep up with school, work, and relationships," said Powell.
If approved by the FDA, Jazz Pharmaceuticals plans to bring Xywav to market for patients with idiopathic hypersomnia in the fourth quarter of 2021. Speaking
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