FDA re­jects As­cendis' parathy­roid can­di­date, spec­i­fy­ing man­u­fac­tur­ing con­cerns

The FDA is­sued a com­plete re­sponse let­ter to As­cendis Phar­ma for palopeg­teri­paratide, a drug-de­vice com­bi­na­tion that is be­ing test­ed as a treat­ment for hy­poparathy­roidism, cit­ing dos­ing prob­lems with the tech­nol­o­gy.

The Dan­ish biotech said Mon­day morn­ing that the reg­u­la­tor’s let­ter cit­ed con­cerns about the “vari­abil­i­ty of de­liv­ered dose.” The com­pa­ny said in ear­ly April that the FDA had “iden­ti­fied de­fi­cien­cies” in the com­pa­ny’s ap­pli­ca­tion for palopeg­teri­paratide, but the agency did not dis­close specifics at the time.

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