FDA cites ‘de­fi­cien­cies’ in As­cendis’ ap­pli­ca­tion for parathy­roid drug, jeop­ar­diz­ing po­ten­tial ap­proval

The FDA is ask­ing for more in­for­ma­tion about As­cendis Phar­ma’s drug for hy­poparathy­roidism, a rare con­di­tion in which the body doesn’t pro­duce enough of a key hor­mone for reg­u­lat­ing cal­ci­um.

In a let­ter, the FDA said it “iden­ti­fied de­fi­cien­cies” in As­cendis’ ap­pli­ca­tion for palopeg­teri­paratide, though the FDA did not dis­close what those de­fi­cien­cies were, ac­cord­ing to As­cendis. The FDA al­so not­ed that the let­ter was not their fi­nal de­ci­sion on the ap­pli­ca­tion, the Dan­ish biotech said.

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