FDA adcomm votes in favor of Ipsen’s fibrodysplasia drug

The FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee vot­ed in sup­port of the ef­fi­ca­cy and risk-ben­e­fit pro­file of Ipsen Bio­phar­ma­ceu­ti­cals’ drug palo­varotene, which the agency is re­view­ing for the treat­ment of the ul­tra-rare dis­ease fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va.

While FDA staff had raised con­cerns about the drug’s safe­ty and ef­fi­ca­cy, the pan­el of out­side ad­vi­sors vot­ed 10-4 that ev­i­dence from a Phase III study showed the drug was ef­fec­tive, and 11-3 that the ben­e­fits of the drug out­weighed its risks.

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