Jazz Pharmaceuticals’ Xywav Gets Orphan Drug Exclusive


By Sam Boughedda

Investing.com – Pharmaceutical Jazz API (NASDAQ 🙂 announced Monday after the bell that the Food and Drug Administration had granted orphan drug exclusivity to its Xywav oral treatment for idiopathic hypersomnia in adults.

This is the second time that orphan drug exclusivity has been granted for the drug after it was previously granted for the treatment of cataplexy, or excessive daytime sleepiness, in patients seven years and older with narcolepsy.

Xywav will have a seven-year market exclusivity for idiopathic hypersomnia effective upon approval by the FDA on August 12, 2021.

The Orphan Drug Designation Program is designed to advance the development of drugs that treat a disease affecting 200,000 US patients or less per year.

“Before the approval of Xywav no treatment has been approved for people living with this unique, debilitating sleep disorder, so we are very proud of how we have advanced the drug from concept to commercial availability and we are encouraged that the FDA recognized by Xywav impact in granting ODE for the treatment of idiopathic hypersomnia, ”said Robert Iannone, executive vice president of research and development and medical director of Jazz Pharmaceuticals.

On Monday, the company’s shares rose 2.83%, to $ 131.01 per share. In after-hours trading, the stock rose 3.83% to $ 136.03.


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