Biopharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) said on Wednesday that it has submitted its New Drug Application (NDA) seeking marketing approval of JZP-258 for treating cataplexy under the US Food and Drug Administration's (FDA) Priority Review.
The Prescription Drug User Fee Act (PDUFA) goal date for the FDA's decision is 21 July 2020.
According to the company, JZP-258 is an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. It is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or about 1,000 to 1,500 milligrams, less sodium than Xyrem (sodium oxybate). Xyrem is the only available product approved to treat both cataplexy and EDS in patients with narcolepsy aged 7 years and older and is the standard of care for treatment of cataplexy.
Cataplexy, the most specific symptom of narcolepsy, is the sudden, generally brief (
Armata Pharmaceuticals announces receipt of FDA Breakthrough Therapy Designation for AP-SA02
GSK reports positive Jideytro data supporting potential first-line lung cancer use
Eloxx Pharmaceuticals commences Phase 2b study of exaluren
Meant Health announces expansion of telehealth access for FDA-approved GLP-1 prescriptions
US FDA grants orphan drug designation for Lundbeck's asedebart
Renova Pharmaceuticals launches first three US generic products
FDA grants Priority Review to Genentech's Enspryng for MOGAD
CordenPharma increases aseptic fill-finish capacity
Biophytis expands BIO101 obesity study to assess weight regain
THX Pharma secures European patent for Batten-1 in juvenile Batten disease
Etcamah–CDK4/6 inhibitor combination approved in US for ESR1-mutated HR-positive breast cancer
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer
Agilent launches S540MD slide scanner system in US
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA