Ascendis Pharma’s hypoparathyroidism drug scores European approval after refiling in the US

As­cendis Phar­ma’s Yorvipath was ap­proved in Eu­rope on Mon­day, days af­ter the com­pa­ny re­filed its ap­pli­ca­tion for the hy­poparathy­roidism hope­ful in the US.

Yorvipath, al­so known as palopeg­teri­paratide, is a pro­drug of the parathy­roid hor­mone, which is made by the parathy­roid glands and con­trols lev­els of cal­ci­um in the blood.

The FDA re­ject­ed the drug ear­li­er this year af­ter reg­u­la­tors raised con­cerns about the “man­u­fac­tur­ing con­trol strat­e­gy for vari­abil­i­ty of de­liv­ered dose in the TransCon PTH drug/de­vice com­bi­na­tion,” ac­cord­ing to As­cendis. The com­pa­ny said at the time that the agency “did not ex­press con­cern” about the clin­i­cal da­ta, and no new pre­clin­i­cal or Phase III stud­ies were re­quest­ed. As­cendis re­filed its new drug ap­pli­ca­tion in the US last week af­ter get­ting some clar­i­ty at an FDA meet­ing in Au­gust.

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