Ascendis Pharma Gets Orphan Drug Exclusivity for Hormone Treatment Yorvipath in U.S.

By Stephen Nakrosis

Ascendis Pharma said the Food and Drug Administration has granted it seven years of orphan drug exclusivity for Yorvipath as a treatment for hypoparathyroidism in adults.

Yorvipath, or palopegteriparatide, is a once-a-day treatment for hypoparathyroidism, a condition which can result in underproduction of parathyroid hormone.

Orphan designation is given to drugs intended to treat a condition affecting fewer than 200,000 people in the U.S., or which won't be profitable within seven years following approval by the FDA, the agency said on its website. Benefits of gaining orphan drug designation include tax credits for qualified clinical trials, exemption from user fees and the potential for seven years of market exclusivity after approval, the FDA said.

An estimated 70,000 to 90,000 people in the U.S. are affected by hypoparathyroidism, Ascendis said.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

September 11, 2024 18:21 ET (22:21 GMT)

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