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By Sam Boughedda
Investing.com — Jazz Prescribed drugs PLC (NASDAQ:) introduced after the bell Monday that the Meals and Drug Administration has granted Orphan Drug Exclusivity for its Xywav oral therapy for idiopathic hypersomnia in adults.
It’s the second time Orphan Drug Exclusivity has been granted for the remedy after it was beforehand granted in treating cataplexy, or extreme daytime sleepiness, in sufferers seven years of age and older with narcolepsy.
Xywav could have seven-year market exclusivity for idiopathic hypersomnia from its FDA approval on August 12, 2021.
The Orphan Drug Designation program is devised to advance the event of medicine that deal with a situation affecting 200,000 or fewer U.S. sufferers per 12 months.
“Previous to the approval of Xywav no remedies had been authorized for folks dwelling with this debilitating and distinctive sleep problem, so we’re very happy with how we superior the drugs from idea to business availability and are inspired that FDA has acknowledged Xywav’s influence by granting ODE for the therapy of idiopathic hypersomnia,” stated Robert Iannone, govt vice chairman of analysis and growth and chief medical officer of Jazz Prescribed drugs.
Monday noticed the corporate’s shares rise 2.83%, to $131.01 per share. In after-hours buying and selling, the inventory has risen 3.83%, to $136.03.
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