FDA Approves Ascendis’ Yorvipath for the Treatment of Hypoparathyroidism

Following its approval earlier this week and the scheduled withdrawal of Takeda’s injection Naptara from the market later this year due to supply difficulties, Ascendis’ Yorvipath has become the only FDA-approved treatment for hypoparathyroidism in the U.S.

Currently, the manufacturing of commercial-grade Yorvipath is underway, with the first batch expected to be ready for U.S. markets by the first quarter of 2025. The price for the drug, which is to be administered once daily, will be made public in the coming week.

Between 70,000 and 90,000 people in the U.S. are affected by this rare endocrine disease, characterized by low levels of parathyroid hormone. As a result of this deficiency, multiple organs in the patients’ bodies are affected.

Dr. Lynn Kohlmeier, M.D., who has served as an investigator in the trials for the condition, shared, “The consequences of hypoparathyroidism on the health and quality of life of our patients can be extraordinarily debilitating.” Dr. Kohlmeier also chairs the Medical Advisory Board of the HypoPARAthyroidism Association and works as an endocrinologist at Spokane Osteoporosis & Endocrinology.

In hypoparathyroidism, the body produces low levels of parathyroid hormone, leading to abnormally low calcium levels, while phosphorus levels in the blood rise.

In the case of Yorvipath, mid to late-stage studies conducted by Ascendis have found that people treated with it do not need to take calcium and vitamin D supplements regularly.

Currently, these supplements are considered the standard of care for patients with hypoparathyroidism.

Ascendis has finally borne fruit with Yorvipath after many setbacks. Last year, issues with the manufacturing controls of the drug-device combination plagued the company, resulting in a rejection. Additionally, before its current approval status, the FDA extended its review of the product in May.
Gavin Clark-Gartner, an Evercore ISI analyst, has estimated peak sales for the product at around $2.5 billion on an adjusted basis, with market penetration for the therapy in the U.S. estimated to be approximately 12.5%.

Ascendis also plans to seek commercialization approval from the FDA for its products that are already manufactured and approved in other markets. If the request receives the green light from the regulatory agency, approved products could be introduced to the U.S. market as soon as the fourth quarter of this year.

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