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Jazz (JAZZ) Submits NDA for Xyrem Follow-On Candidate JZP-258 (Revised)
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Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that it has submitted a new drug application (“NDA”), seeking approval for JZP-258 as a treatment for cataplexy and excessive daytime sleepiness (“EDS”) associated with narcolepsy in patients seven years or older.
The company has redeemed a priority review voucher for the NDA submission, which may lead to accelerated review of the regulatory application.
JZP-258 is a follow-on candidate of the company’s blockbuster sleep disorder drug, Xyrem. It is an oxybate product candidate with 92% less sodium content than Xyrem, which is also approved for cataplexy or EDS sleepiness associated with narcolepsy.
Jazz’s shares have increased 15.5% in the past year compared with the industry’s rise of 0.8%.
The NDA for JZP-258 was supported by data from a phase III study, which evaluated JZP-258 for change in weekly cataplexy attacks compared to a placebo. Data from the study demonstrated highly statistically significant differences in the number of cataplexy attacks as well as in key secondary endpoint of change in Epworth Sleepiness Scale (ESS) score for JZP-258 versus placebo. The candidate has a safety profile similar to Xyrem.
The company has a strong sleep disorder portfolio with two FDA-approved drugs — Xyrem and Sunosi (solriamfetol). Xyrem is its key revenue generator with estimated full-year sales in the range of $1.6-$1.64 billion. Meanwhile, Sunosi was launched in the United States for treating EDS in patients with narcolepsy (with or without cataplexy) or obstructive sleep apnea in July 2019. The drug generated nearly $1 million in sales since its launch till the third quarter of 2019. Potential approval to JZP-258 will boost Jazz’s sleep disorder portfolio further.
JZP-258 is likely to expand the eligible patient population for Jazz’s medicines as it will include patients ineligible for Xyrem as they are at risk of high sodium intake-related consequences, including hypertension and other cardiovascular diseases. The highest approved dose of Xyrem of 9 grams per night contains 1,640 mg of sodium, which is almost 70% of the recommended daily sodium intake for a healthy adult per an article published on FDA’s website.
Moreover, generic version of Xyrem is set to hit the market starting 2023. The low sodium content of JZP-258 and a similar safety profile are likely to largely offset the decline in Xyrem sales once generic versions enter the market.
Approved drugs for narcolepsy include Teva Pharma’s (TEVA - Free Report) Provigil and Novartis’ (NVS - Free Report) Ritalin-SR. A few other pharma companies are also developing treatment for narcolepsy, which includes Avadel Pharmaceuticals (AVDL - Free Report) .
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Jazz (JAZZ) Submits NDA for Xyrem Follow-On Candidate JZP-258 (Revised)
Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that it has submitted a new drug application (“NDA”), seeking approval for JZP-258 as a treatment for cataplexy and excessive daytime sleepiness (“EDS”) associated with narcolepsy in patients seven years or older.
The company has redeemed a priority review voucher for the NDA submission, which may lead to accelerated review of the regulatory application.
JZP-258 is a follow-on candidate of the company’s blockbuster sleep disorder drug, Xyrem. It is an oxybate product candidate with 92% less sodium content than Xyrem, which is also approved for cataplexy or EDS sleepiness associated with narcolepsy.
Jazz’s shares have increased 15.5% in the past year compared with the industry’s rise of 0.8%.
The NDA for JZP-258 was supported by data from a phase III study, which evaluated JZP-258 for change in weekly cataplexy attacks compared to a placebo. Data from the study demonstrated highly statistically significant differences in the number of cataplexy attacks as well as in key secondary endpoint of change in Epworth Sleepiness Scale (ESS) score for JZP-258 versus placebo. The candidate has a safety profile similar to Xyrem.
The company has a strong sleep disorder portfolio with two FDA-approved drugs — Xyrem and Sunosi (solriamfetol). Xyrem is its key revenue generator with estimated full-year sales in the range of $1.6-$1.64 billion. Meanwhile, Sunosi was launched in the United States for treating EDS in patients with narcolepsy (with or without cataplexy) or obstructive sleep apnea in July 2019. The drug generated nearly $1 million in sales since its launch till the third quarter of 2019. Potential approval to JZP-258 will boost Jazz’s sleep disorder portfolio further.
JZP-258 is likely to expand the eligible patient population for Jazz’s medicines as it will include patients ineligible for Xyrem as they are at risk of high sodium intake-related consequences, including hypertension and other cardiovascular diseases. The highest approved dose of Xyrem of 9 grams per night contains 1,640 mg of sodium, which is almost 70% of the recommended daily sodium intake for a healthy adult per an article published on FDA’s website.
Moreover, generic version of Xyrem is set to hit the market starting 2023. The low sodium content of JZP-258 and a similar safety profile are likely to largely offset the decline in Xyrem sales once generic versions enter the market.
Approved drugs for narcolepsy include Teva Pharma’s (TEVA - Free Report) Provigil and Novartis’ (NVS - Free Report) Ritalin-SR. A few other pharma companies are also developing treatment for narcolepsy, which includes Avadel Pharmaceuticals (AVDL - Free Report) .
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Zacks Rank
Jazz currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
(We are reissuing this article to correct a mistake. The earlier article on this topic, issued on January 23, 2020, should no longer be relied upon.)