Ascendis Pharma resubmits NDA for TransCon PTH to U.S. FDA

Ascendis Pharma A/S announced that it has resubmitted its New Drug Application for TransCon PTH for the treatment of adults with hypoparathyroidism to the U.S. Food & Drug Administration. The resubmission follows the Type A meeting held with the FDA in late August. “Ascendis Pharma remains committed to providing a treatment option that addresses the underlying disease pathophysiology for patients living with hypoparathyroidism,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “With results from two randomized, double-blind, placebo-controlled clinical trials of TransCon PTH and no new safety concerns identified in follow-up reaching up to four years, we believe TransCon PTH is well-positioned to meet the needs of the hypoparathyroidism community. As no concerns were expressed by the FDA about the clinical data submitted as part of our original NDA, we look forward to working with the agency during its review of our updated manufacturing control strategy for TransCon PTH in the United States.”