FDA approves Yorvipath
The US Food and Drug Administration (FDA) has approved Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults, from Ascendis Pharma (Nasdaq: ASND).
The Danish company’s shares rose 7.6% to $136.62 on the welcome news, given a couple of setbacks - including an extension of FDA review in May, and a rejection of approval last year, on concerns linked to manufacturing controls of the drug and device combination.
Yorvipath, will become the only approved treatment for hypoparathyroidism, in the USA, after rival Takeda (TYO: 4502) stops manufacturing its injectable parathyroid hormone Natpara at the end of this year due to supply issues.
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