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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER