Ascendis Pharma has announced that its hormone disorder therapy has failed to win approval from the US Food and Drug Administration (FDA). The therapy, called TransCon hGH, is designed to treat growth hormone deficiency in children and adults.
In a statement, Ascendis Pharma said that the FDA had issued a Complete Response Letter (CRL) for TransCon hGH, indicating that the agency was not ready to approve the therapy at this time. The FDA cited concerns about the manufacturing process for TransCon hGH, as well as the clinical data supporting its efficacy and safety.
Despite the setback, Ascendis Pharma remains committed to developing and commercializing TransCon hGH. The company plans to work closely with the FDA to address the agency’s concerns and to move the therapy towards approval.
Growth hormone deficiency is a rare condition that affects both children and adults. It can cause a range of symptoms, including short stature, delayed puberty, and decreased bone density. Currently, there are only a few treatments available for growth hormone deficiency, and there is a significant need for new therapies that can help patients manage their symptoms.
TransCon hGH is a long-acting therapy that is designed to provide sustained release of growth hormone over a period of several weeks. The therapy has shown promise in clinical trials, with some patients experiencing significant improvements in their symptoms.
Despite the FDA’s decision not to approve TransCon hGH at this time, Ascendis Pharma remains optimistic about the therapy’s potential. The company believes that TransCon hGH could provide a significant benefit to patients with growth hormone deficiency, and it plans to continue working towards approval for the therapy in the future.
