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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