EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The Eu­ro­pean Med­i­cines Agency’s com­mit­tee for med­i­c­i­nal prod­ucts for hu­man use (CHMP) on Fri­day rec­om­mend­ed re­vok­ing the mar­ket­ing au­tho­riza­tion for No­var­tis’ treat­ment for a painful com­pli­ca­tion re­lat­ed to sick­le cell, af­ter a re­cent study did not con­firm its clin­i­cal ben­e­fit.

CHMP’s re­view looked at re­sults of the STAND study, find­ing that Adakveo (crizan­l­izum­ab) did not re­duce the num­ber of painful crises lead­ing to a health­care vis­it, and pa­tients treat­ed with Adakveo had slight­ly more painful crises on av­er­age, with a sub­se­quent health­care vis­it, over the first year of treat­ment, com­pared with those on place­bo.

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