Country for PR: Hong Kong
Contributor: PR Newswire Asia (Hong Kong)
Monday, June 24 2019 - 19:00
FDA Grants Orphan Drug Designation to XW Laboratories' XWL-008 for the Treatment of Patients with Narcolepsy
WUHAN, China, June 24, 2019 /PRNewswire-AsiaNet/ --

XW Laboratories Inc. (XW Labs), a clinical-stage biopharmaceutical company 
pioneering the discovery of novel small molecule therapeutics for the treatment 
of neurological disorders, today announced that the U.S. Food and Drug 
Administration (FDA) has granted Orphan Drug Designation to the company's lead 
proprietary compound XWL-008 for the treatment of patients with narcolepsy. 

"We are delighted to receive Orphan Drug Designation for XWL-008 for the 
treatment of narcolepsy. We continue to be committed to the development of 
XWL‑008 as the potential first-line treatment for this rare and 
debilitating disorder," said Dr. Jia-Ning Xiang, Founder and CEO of XW Labs. 
"We have recently reached a major milestone in XWL-008 development by 
successfully completing Phase 1 studies, yielding robust results demonstrating 
favorable safety, tolerability, and pharmacokinetics. We are now preparing for 
late-stage phase 3 clinical research and a 505(b)(2) NDA regulatory pathway as 
the next step to bringing this novel drug candidate to narcolepsy patients 

The FDA Orphan Drug Designation program grants orphan status to promising 
investigational drugs designed to treat, prevent, or diagnose rare medical 
diseases or conditions that affect fewer than 200,000 individuals in the United 
States. Orphan designation qualifies sponsors for several key benefits and 
incentives, including tax credits for clinical testing, exemption from 
marketing application user fees, and seven-year marketing exclusivity upon FDA 

About Narcolepsy
Narcolepsy is a chronic neurological sleep disorder in patients with abnormal 
regulation of their sleep-wake cycle. This disorder is typically characterized 
by excessive daytime sleepiness and cataplexy (sudden muscle weakness triggered 
by emotion), among other symptoms. Approximately 1 in 2,000 individuals in the 
US as well as 3 million individuals worldwide suffer from this disorder. 

About XW Laboratories Inc.
XW Laboratories Inc. (XW Labs) is a clinical-stage biopharmaceutical company 
focused on the development of novel compounds for the treatment of neurological 
disorders with primary research and development activities located in Wuhan, 
Mainland China and New Taipei City, Taiwan. XW Labs' expertise in drug design 
and specialized drug platforms provide critical competitive advantages to 
shortening the time it takes to identify best-in-class development candidates.

SOURCE: XW Laboratories Inc.