GENE ONLINE|News &
Opinion
Blog

2021-08-13| Trials & Approvals

Jazz Pharma’s Xywav Becomes First FDA Approved Drug for a Rare Neurologic Disease

by Rajaneesh K. Gopinath
Share To

Dublin-based biopharma Jazz Pharmaceuticals is on a roll notching its second FDA approval in two months. After snagging a win for its blood cancer drug, Rylaze, in June, it has now bagged US approval for Xywav, its sleep disorder drug, for a second indication. 

Xywav is a lower-sodium oxybate first FDA approved in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy. On August 12th, the drug became the first to get approved for treating idiopathic hypersomnia (IH), a rare neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

“Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Eric Bastings, M.D., Deputy Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

“We are excited that with today’s approval, Xywav will become the first and only medicine indicated to treat idiopathic hypersomnia, a unique medical condition that can have significant effects on the lives of those diagnosed with the condition,” said Bruce Cozadd, Chairman, and CEO of Jazz Pharmaceuticals

 

Positive Phase 3 Results

The approval is based on the drug’s strong showing in a Phase 3, double-blind, placebo-controlled withdrawal study conducted in 154 adult patients with IH. Results showed that as compared to placebo, Xywav demonstrated statistically significant and clinically meaningful differences in various standard sleepiness scores, the primary and secondary endpoints of the trial.

“Having an FDA-approved treatment option that manages symptoms associated with idiopathic hypersomnia, including excessive daytime sleepiness and severe sleep inertia, is a significant step forward for patients. Xywav fulfills an unmet need for those diagnosed with this sleep disorder, offering them management of their debilitating symptoms,” said Yves Dauvilliers, M.D., the lead investigator of the study.

The most common adverse events as a result of the treatment observed in the study included nausea, headache, dizziness, insomnia, anxiety, and vomiting. The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. Therefore, the drug comes with a boxed warning for central nervous system depression and abuse, and misuse.

According to Coherent Market Insights, the global IH treatment market is estimated to surpass $429 million by 2027, with an anticipated CAGR of 8.7%. With no competitors in the space, Jazz will be hoping to dominate the IH market for quite some time to come.

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
FDA Greenlights First In-Vitro Alzheimer’s Diagnostic
2022-05-05
Novo Nordisk’s Type 2 Diabetes Drug Gets Greenlight in Korea
2022-05-04
A New Nonstimulant ADHD Medication For Adults Gets FDA Approval
2022-05-03
LATEST
Recounting 25 Years of Genetic and Human Diversity Discovery With deCODE Founder Kari Stefansson
2022-05-26
Servier Announces FDA Approval of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
2022-05-25
These Companies Are Harnessing Oncolytic Viruses to Target Cancer
2022-05-25
Lonza Signs CDMO Deal to Break Into Israeli Market
2022-05-25
EU Expands Merck’s Keytruda Use on Breast Cancer
2022-05-25
Travecta Therapeutics Announces In-Person Presentation at 2022 BIO International Convention
2022-05-24
Global Race to Track and Contain Monkeypox Outbreak
2022-05-24
EVENT
2022-06-03
ASCO Annual Meeting
Online and on-side
2022-06-07
Digital RESI June
Online
2022-06-09
Medhospafrica
Africa
2022-06-13
BIO International Convention
San Diego, CA
2022-12-14
BIOHK2022
Hong Kong, China
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!