Eu­ro­pean Com­mis­sion re­jects Ipsen's ul­tra-rare dis­ease drug af­ter two neg­a­tive opin­ions from EMA

The Eu­ro­pean Com­mis­sion has re­ject­ed Ipsen’s po­ten­tial new drug palo­varotene for those with the ul­tra-rare ge­net­ic con­nec­tive tis­sue dis­or­der known as fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va, or FOP.

The de­ci­sion fol­lows two neg­a­tive opin­ions from the Eu­ro­pean Med­i­cines Agency in Jan­u­ary and May. And where­as the US FDA re­cent­ly said it might be open to a post-hoc analy­sis of a failed late-stage tri­al for palo­varotene, the EMA said in May:

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