LONDON — Reversing an earlier decision, European regulators on Thursday recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved, saying that the benefits of the treatment outweigh the risks in a select group of patients.
A European Medicines Agency committee had said in July that the medicine, called Leqembi, should be rejected, citing the modest benefits seen in trials and the potentially dangerous side effects that accompany the drug.
But following an appeal from the companies, through what’s called a re-examination process, the committee on Thursday said it had concluded that, for certain patients, “the benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks.”
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