Hal­loween ad­comm post­poned as FDA seeks more Ipsen da­ta on ul­tra rare dis­or­der drug can­di­date

In a new set­back for Paris-based Ipsen, the FDA is post­pon­ing an ad­comm meet­ing that was set for Oct. 31 to re­view new in­for­ma­tion on the com­pa­ny’s pre­vi­ous­ly spurned po­ten­tial treat­ment of pa­tients with fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va, an ul­tra-rare ge­net­ic dis­or­der.

The FDA said the post­pone­ment is “to al­low time for the FDA to re­view new in­for­ma­tion,” while Ipsen said “the post­pone­ment re­lates to an FDA re­quest for new in­for­ma­tion on palo­varotene clin­i­cal tri­al da­ta and does not re­late to the safe­ty pro­file of palo­varotene. The com­pa­ny is cur­rent­ly work­ing to ful­fill the re­quest.”

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