Biogen pulls EU application for Alzheimer’s drug Aduhelm
pharmaphorum
APRIL 24, 2022
Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it clear the current data for the drug is not sufficient to get it past the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision does not come as a big surprise, given that the CHMP said in December it was unconvinced by the data submitted for the drug.
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