Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use on Fri­day re­ject­ed Ipsen Phar­ma’s po­ten­tial treat­ment for a rare ge­net­ic dis­ease known as fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va (FOP), which caus­es ex­tra bone to form out­side the skele­ton.

The EMA said on its web­site that it could not draw any firm con­clu­sions on the ben­e­fits of the French bio­phar­ma’s So­honos (palo­varotene), which se­lec­tive­ly tar­gets the retinoic-acid re­cep­tor gam­ma (RARγ), “as the ap­pli­cant’s con­clu­sion was based on a post-hoc analy­sis which was nei­ther sci­en­tif­i­cal­ly nor clin­i­cal­ly jus­ti­fied and pre-spec­i­fied study ob­jec­tives were not met.”

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