ReViral Announces FDA Fast Track Designation Granted to Sisunatovir For The Treatment of Serious Respiratory Syncytial Virus Infection
ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection. Sisunatovir is the company’s most advanced product candidate, with two international multicentre Phase 2 clinical studies recently initiated in pediatric and high-risk adult patient populations.
“We are very pleased that sisunatovir has received Fast Track designation for the treatment of serious RSV, a significant global health concern” said Alex Sapir, CEO, ReViral. “RSV affects approximately 64 million people and causes approximately 160,000 deaths each year. We look forward to working closely with the FDA throughout the clinical development of this program with the goal of bringing a potentially life-saving treatment to patients as quickly as possible.”
Fast Track is a process intended to facilitate the development and expediate the review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate’s development, review, and potential approval.
News source: ReViral.
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