Post by luxetvox on Dec 5, 2022 13:54:55 GMT
ASND: Ascendis Pharma to initiate TransCon PTH U.S. expanded access program
2022-12-05 13:08:30.754 GMT
Ascendis Pharma announced that the U.S. Food & Drug Administration, FDA, has
allowed the Company to initiate an expanded access program for its
investigational parathyroid hormone replacement therapy, TransCon PTH, for
adult patients with hypoparathyroidism. To qualify, patients must live in the
U.S., have PTH treatment experience, and have medical needs that cannot be
addressed by commercial products or clinical trials. TransCon PTH is an
investigational prodrug in development for adult patients with
hypoparathyroidism. The safety and efficacy of TransCon PTH have not been
established and TransCon PTH is not currently approved by the FDA. It is
currently under Priority Review by the FDA, with a Prescription Drug User Fee
Act target action date of April 30, 2023.
2022-12-05 13:08:30.754 GMT
Ascendis Pharma announced that the U.S. Food & Drug Administration, FDA, has
allowed the Company to initiate an expanded access program for its
investigational parathyroid hormone replacement therapy, TransCon PTH, for
adult patients with hypoparathyroidism. To qualify, patients must live in the
U.S., have PTH treatment experience, and have medical needs that cannot be
addressed by commercial products or clinical trials. TransCon PTH is an
investigational prodrug in development for adult patients with
hypoparathyroidism. The safety and efficacy of TransCon PTH have not been
established and TransCon PTH is not currently approved by the FDA. It is
currently under Priority Review by the FDA, with a Prescription Drug User Fee
Act target action date of April 30, 2023.
