Agios might have a European problem
Last week, European regulators turned down Agios Pharmaceuticals’ Bristol-Myers Squibb-partnered cancer drug in what could be a bad omen for the company’s ambitions with a second, wholly owned treatment.
As STAT’s Adam Feuerstein reports, the European Medicines Agency concluded that the evidence supporting Idhifa, a treatment acute myeloid leukemia, wasn’t sufficient to support approval. That evidence, data from a single-arm study, was enough to convince the FDA in 2017.
It’s also quite similar to the evidence in support of Tibsovo, a follow-on AML therapy. Unlike with Idhifa, Agios doesn’t have to share Tibsovo sales with anyone, making the drug key to the company’s future. But if the EMA’s take on Idhifa is a preview of the next review, Agios’s plans might get interrupted.
Read more.
As STAT’s Adam Feuerstein reports, the European Medicines Agency concluded that the evidence supporting Idhifa, a treatment acute myeloid leukemia, wasn’t sufficient to support approval. That evidence, data from a single-arm study, was enough to convince the FDA in 2017.
It’s also quite similar to the evidence in support of Tibsovo, a follow-on AML therapy. Unlike with Idhifa, Agios doesn’t have to share Tibsovo sales with anyone, making the drug key to the company’s future. But if the EMA’s take on Idhifa is a preview of the next review, Agios’s plans might get interrupted.
Read more.
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