Jazz Pharmaceuticals' SNDA For Xyrem Gets Priority Review
Zacks Investment Research | Jun 27, 2018 10:51PM ET
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) announced that the FDA has accepted the supplemental new drug application (sNDA) for narcolepsy drug, Xyrem. The sNDA is seeking label expansion of the drug for the treatment for cataplexy and excessive daytime sleepiness (“EDS”) in pediatric patients. The FDA has granted priority review to the sNDA and a decision is expected by Oct 27, 2018.
The drug is currently approved to treat the same indications in adult patients.
Shares of the company have rallied 29.6% so far this year against the industry 's 2.1% decrease.
The sNDA included data from long-term phase II/III EXPRESS study evaluating Xyrem in patients aged seven to 17 years. The study was initiated upon request from the FDA. Data showed that Xyrem reduced cataplexy and EDS for up to one year in such patients.
Xyrem is the majority revenue source for the company, generating three-quarters of the total sales. Xyrem’s sales were $316.8 million in the first quarter of 2018. A potential approval in pediatric patients will likely boost sales as the eligible patient population increases.
However, several companies are also developing their candidates for the treatment of cataplexy and EDS in narcolepsy patients including Avadel Pharmaceuticals plc (NASDAQ:AVDL) . Moreover, a few companies are trying to bring the generic version of Xyrem in the market. Jazz has settled such litigations with some companies including privately-held West-Ward Pharmaceuticals and Par Pharmaceutical, which have restricted a generic entry till Jan 1, 2023.
The entry of either a branded or generic drug is expected to severely impact Jazz’s top line.
Apart from Xyrem, Jazz’s another narcolepsy candidate, JZP-110, is under review for the treatment of EDS. A decision is expected in December.
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