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Jazz's (JAZZ) Xywav Gets FDA Nod for Idiopathic Hypersomnia
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Jazz Pharmaceuticals (JAZZ - Free Report) announced that the FDA has approved its new sleep medicine, Xywav oral solution, to treat adult patients with idiopathic hypersomnia (“IH”), a chronic neurological disorder characterized by excessive daytime sleepiness (“EDS”). Following approval, Xywav is the first FDA approved drug to treat the given indication.
FDA approval for the drug is based on data from a phase III study that demonstrated Xywav’s efficacy and safety in the treatment of IH in adults. Treatment with Xywav achieved statistically significant and clinically meaningful differences in the Epworth Sleepiness Scale score, the primary endpoint of the above-mentioned study. Also, treatment with Xywav achieved meaningful differences in the Patient Global Impression of Change and the Idiopathic Hypersomnia Severity Scale, which were the secondary endpoints of the study.
Shares of Jazz have declined 11.8% so far this year in comparison with the industry’s 12.3% decline.
Image Source: Zacks Investment Research
The company plans to commercially launch Xywav for IH indication in second-half 2021, following the implementation of Risk Evaluation and Mitigation Strategies (“REMS”). Dosing regimens for the drug will include twice- and once-nightly option based on efficacy as well as tolerability.
Xywav was first approved in July 2020 for the treatment of cataplexy and EDS in narcolepsy patients aged seven years and above. The drug generated $75.4 million in sales in first-quarter 2021, the first full quarter of sales for the drug. Following commercial launch for IH indication, Xywav sales are expected to be higher in the future quarters.
Xywav is a low sodium formulation of Jazz’s key sleep disorder drug Xyrem. The low sodium content of the same boosts its potential, as it can cater to a greater number of patients than Xyrem. Xywav received Fast Track and Priority Review designations from the FDA in September 2020 and April 2021, respectively, for the IH indication.
Earlier this week, Jazz announced that GW Pharmaceuticals, its newly acquired subsidiary, received an approval from the UK Medicines and Healthcare Products Regulatory Agency for expanded use of Epidyolex (cannabidiol) — a cannabis-based oral solution — to treat tuberous sclerosis complex associated seizures.
Catalent’s stock has risen 15.6% in the year so far.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 46% in the year so far.
Ironwood’s earnings per share estimates for 2021 have increased from $1.05 to $2.04 in the past 30 days. The same for 2022 has risen from $1.18 to $1.72 over the same period. The stock has rallied 21.5% in the year so far.
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Jazz's (JAZZ) Xywav Gets FDA Nod for Idiopathic Hypersomnia
Jazz Pharmaceuticals (JAZZ - Free Report) announced that the FDA has approved its new sleep medicine, Xywav oral solution, to treat adult patients with idiopathic hypersomnia (“IH”), a chronic neurological disorder characterized by excessive daytime sleepiness (“EDS”). Following approval, Xywav is the first FDA approved drug to treat the given indication.
FDA approval for the drug is based on data from a phase III study that demonstrated Xywav’s efficacy and safety in the treatment of IH in adults. Treatment with Xywav achieved statistically significant and clinically meaningful differences in the Epworth Sleepiness Scale score, the primary endpoint of the above-mentioned study. Also, treatment with Xywav achieved meaningful differences in the Patient Global Impression of Change and the Idiopathic Hypersomnia Severity Scale, which were the secondary endpoints of the study.
Shares of Jazz have declined 11.8% so far this year in comparison with the industry’s 12.3% decline.
Image Source: Zacks Investment Research
The company plans to commercially launch Xywav for IH indication in second-half 2021, following the implementation of Risk Evaluation and Mitigation Strategies (“REMS”). Dosing regimens for the drug will include twice- and once-nightly option based on efficacy as well as tolerability.
Xywav was first approved in July 2020 for the treatment of cataplexy and EDS in narcolepsy patients aged seven years and above. The drug generated $75.4 million in sales in first-quarter 2021, the first full quarter of sales for the drug. Following commercial launch for IH indication, Xywav sales are expected to be higher in the future quarters.
Xywav is a low sodium formulation of Jazz’s key sleep disorder drug Xyrem. The low sodium content of the same boosts its potential, as it can cater to a greater number of patients than Xyrem. Xywav received Fast Track and Priority Review designations from the FDA in September 2020 and April 2021, respectively, for the IH indication.
Earlier this week, Jazz announced that GW Pharmaceuticals, its newly acquired subsidiary, received an approval from the UK Medicines and Healthcare Products Regulatory Agency for expanded use of Epidyolex (cannabidiol) — a cannabis-based oral solution — to treat tuberous sclerosis complex associated seizures.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech/drug sector include Catalent (CTLT - Free Report) , Horizon Therapeutics and Ironwood Pharmaceuticals (IRWD - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Catalent’s stock has risen 15.6% in the year so far.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 46% in the year so far.
Ironwood’s earnings per share estimates for 2021 have increased from $1.05 to $2.04 in the past 30 days. The same for 2022 has risen from $1.18 to $1.72 over the same period. The stock has rallied 21.5% in the year so far.