ContraVir Pharmaceuticals Announces TXL Has Been Granted Orphan Drug Designation for the Treatment of HBV in a Pediatric Population

ContraVir Pharmaceuticals (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead investigational drug candidate, tenofovir exalidex (TXL™) for the treatment of chronic hepatitis B infection in a pediatric patient population (0 to 11 years old).

As quoted in the press release:

“We are very pleased to report that TXL™ is currently the only investigational or approved HBV treatment granted orphan designation for the pediatric patient population,” said James Sapirstein, Chief Executive Officer at ContraVir. “This designation underscores the significant unmet need in this highly vulnerable patient population and provides a critical development path for TXL™ to bring to market a new treatment option for this under-served patient population. As we previously reported the agreement with FDA on the 505(b)(2) registration pathway for TXL™, we have achieved yet another important regulatory milestone, and we look forward to continued collaboration with the FDA addressing the urgency of successfully developing treatments for hepatitis B in the pediatric and adult populations.”

Click here to read the full press release.