Eu­ro­pean reg­u­la­tors spurn Agios' AML drug Tib­so­vo, un­con­vinced by the same thin PhI da­ta that won over the FDA

Eu­ro­pean reg­u­la­tors aren’t as im­pressed with Agios’ sin­gle-arm da­ta from the Phase I study for Tib­so­vo as the FDA proved to be 2 years ago.

Agios not­ed af­ter the bell on Fri­day that the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use turned thumbs down on the ear­ly-stage da­ta on the drug, de­signed for AML pa­tients with an IDH1 mu­ta­tion. And that forced Agios to pull its ap­pli­ca­tion.

Agios won an FDA OK for the treat­ment in the sum­mer of 2018 with a round of da­ta from a sin­gle-arm study with no con­trol arm, leav­ing the com­pa­ny to push ahead with Phase III con­fir­ma­to­ry stud­ies, which are now en­rolling pa­tients.

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