FDA re­jects Ipsen rare-dis­ease drug, more da­ta and time need­ed to re­view

The FDA re­ject­ed Ipsen’s ul­tra-rare dis­ease drug palo­varotene, the com­pa­ny said, and has asked for more da­ta from ex­ist­ing stud­ies that will push an­oth­er re­view out by more than six months.

The de­lay is the lat­est blow to the com­pa­ny’s at­tempts to get the drug ap­proved in the US. In Oc­to­ber, the agency post­poned an ad­vi­so­ry com­mit­tee meet­ing to re­view the drug, say­ing that it need­ed more time to re­view da­ta from the com­pa­ny that it had re­quest­ed.

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