Ascendis’ hormone replacement therapy hit with three-month FDA review delay

2024-05-15

临床2期临床3期临床结果

Ascendis Pharma is facing another setback on its journey to win approval for TransCon TransCon PTH (palopegteriparatide) to treat hypoparathyroidism. The FDA on Tuesday extended its review of the hormone replacement therapy by three months and now expects to make a decision by August 14.

According to Ascendis, the FDA needs more time to review new information submitted by the company, which constituted a major amendment to its application for TransCon PTH.

“We have responded to all requests received to date from the FDA and will work with the agency as they continue their review,” said CEO Jan Mikkelsen.

The delay follows a complete response letter from the US regulator last year, which cited issues with the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combo, but did not raise any concerns with the investigational drug’s efficacy or safety.

Ascendis’ application for TransCon PTH includes data from the Phase III PaTHway and Phase II PaTH Forward trials, which showed that 79% and 86% of treated patients, respectively, achieved normalisation of serum calcium and independence from conventional therapy at six months of treatment.

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