Ascendis’ hypoparathyroidism drug saddled with three-month delay at FDA

As­cendis Phar­ma will like­ly wait three more months to get an an­swer from the FDA on the re­view of its hy­poparathy­roidism drug.

On Tues­day, As­cendis an­nounced that US reg­u­la­tors had de­layed their de­ci­sion on the drug, TransCon PTH (al­so known as palopeg­teri­paratide), be­cause of a “ma­jor amend­ment” to the com­pa­ny’s ap­pli­ca­tion.

It’s yet an­oth­er hur­dle for a drug that’s al­ready been re­ject­ed once. Last May, the FDA re­ject­ed As­cendis’ ap­pli­ca­tion, cit­ing “con­cerns re­lat­ed to the man­u­fac­tur­ing con­trol strat­e­gy for vari­abil­i­ty of de­liv­ered dose.” A month pri­or, the FDA had asked for more in­for­ma­tion on the drug af­ter find­ing “de­fi­cien­cies” in the new drug ap­pli­ca­tion.

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