Ascendis Pharma Says FDA Extending Review Period for NDA

By Ben Glickman

Ascendis Pharma said regulators had pushed back the target action date for reviewing its hypoparathyroidism treatment after the company submitted additional information.

The Danish biopharmaceutical company said Tuesday that the U.S. Food and Drug Administration had informed the company that its new target date was Aug. 14, compared with its previous date of May 14.

Ascendis's new drug application for TransCon, or palopegteriparatide, in treatment of adults with hypoparathyroidism was accepted by the FDA in December.

The FDA can extend review periods for NDAs if there are major amendments to the applications.

Ascendis Chief Executive Jan Mikkelsen said the company had responded to all requests received from FDA at this point and is committed to bringing the treatment to patients.

Write to Ben Glickman at [e-mail]

(END) Dow Jones Newswires

05-14-24 1511ET