The fu­ture of Ipsen’s new $1.3B drug is in doubt as safe­ty fears force the FDA to slam the brakes on late-stage stud­ies

Just 9 months af­ter buy­ing Clemen­tia for $1.3 bil­lion to ac­quire its lead rare dis­ease drug palo­varotene, the FDA has forced Ipsen to slam the brakes on treat­ing chil­dren in late-stage stud­ies un­der­way for the ther­a­py.

Of­fi­cial­ly this is a par­tial hold, says Paris-based Ipsen, as the feds are or­der­ing a halt to dos­ing of pa­tients 14 and un­der in Phase II tri­als and a Phase III study for fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va (FOP) and mul­ti­ple os­teo­chon­dro­mas (MO). But all of the pa­tients in the MO study are lim­it­ed to 14 and be­low, so all dos­ing will stop there.

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