Benzinga | Jun 14, 2021 09:01AM EDT

Ascendis Pharma On Friday Announced Extension Of FDA Review Period For TransCon hGH (Lonapegsomatropin) For Pediatric Growth Hormone Deficiency

Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create new product candidates that address unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information the Company submitted in connection with the FDA's ongoing review of the Biologics License Application (BLA) for lonapegsomatropin for the treatment of pediatric growth hormone deficiency (GHD) constituted a major amendment to the BLA. Accordingly, the FDA has extended the Prescription Drug User Fee Act goal date by three months, to September 25, 2021.



"We have responded to all outstanding questions from the FDA and believe the complete package we have submitted satisfies all of FDA's requests and will enable a complete review of the application of lonapegsomatropin for pediatric GHD," said Jan Mikkelsen, Ascendis Pharma's President and Chief Executive Officer. "We are committed to making lonapegsomatropin the market-leading therapy for treating pediatric GHD and look forward to continuing interactions with the FDA during the remainder of the review process."