Jazz Pharmaceuticals plc — Xywav FDA Review (NDA212690, ORIG 1, 2020)

Jazz Pharmaceuticals plc · 2020 · FDA Review (openFDA) · company profile →

Report summary

This report summarizes the FDA's clinical review of Jazz Pharmaceuticals' NDA 212690 for JZP-258 (Xywav), a lower-sodium alternative to Xyrem, for treating cataplexy and excessive daytime sleepiness in narcolepsy patients aged 7 and older. Efficacy was primarily demonstrated in Study 15-006, which showed statistically significant superiority of JZP-258 over placebo for both primary and key secondary endpoints, including reductions in cataplexy attacks and improved Epworth Sleepiness Scale scores. The safety profile was consistent with oxybate. The report also covers pharmacokinetic studies and regulatory recommendations for approval, including pediatric use and controlled substance scheduling.

Key findings — cited to the page

Deaths during main study	0	· p.39
JZP-258 IND	49641	JZP-258 · p.11
Primary efficacy endpoint (weekly cataplexy attacks)	statistically significant superiority	JZP-258 · p.31
Key secondary efficacy endpoint (Epworth Sleepiness Scale score)	statistically significant superiority	JZP-258 · p.33
NDA Serial Number	212690 (0001)	JZP-258 · p.2
Correspondence Date	1/21/20	· p.2
Date Received By Reviewer	1/21/20	· p.2
Date Review Completed	7/21/20	· p.2
Proposed Indication	Narcolepsy	JZP-258 · p.2
Recommendation for approval	approved	JZP-258 · p.3
Proposed Indication	treatment of cataplexy and excessive daytime sleepiness in patients 7 years of age and older with narcolepsy	JZP-258 · p.3
Study 15-006 objective	evaluate the efficacy of JZP-258 in the treatment of cataplexy in patients with narcolepsy	JZP-258 · p.4

Source: Jazz Pharmaceuticals plc ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →