FDA Approves Sandoz and Ascendis Pharma’s Treatments for nAMD and Hypoparathyroidism

FDA Approval for Ascendis Pharma's Yorvipath:

The FDA has approved Ascendis Pharma's Yorvipath (palopegteriparatide) for the treatment of hypoparathyroidism in adults.
Yorvipath is the first and only approved treatment for hypoparathyroidism in the United States.

Sandoz's Approval for nAMD:

Sandoz has received FDA approval for a treatment for neovascular age-related macular degeneration (nAMD).

Background on Hypoparathyroidism:

Hypoparathyroidism is a condition characterized by impaired parathyroid gland function, leading to symptoms such as headaches, muscle cramps, and weakness.
Prior to Yorvipath's approval, there were no dedicated therapies for hypoparathyroidism, with patients managed using high-dose calcium and active vitamin D therapy.

Yorvipath's Mechanism:

Yorvipath is a long-acting prodrug of the parathyroid hormone, administered via a once-daily subcutaneous injection, helping to restore physiologic levels of the parathyroid hormone for 24 hours.

Previous Delays and Resubmission:

The FDA previously rejected Yorvipath in May 2023 due to manufacturing concerns but found no issues with its safety and efficacy.
Ascendis resubmitted the application in late 2023, and after an additional data submission, the FDA extended the decision date by three months.