Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.

Progressive and incurable, Alzheimer’s disease affects an estimated 6.7 million U.S. adults at least 65 years old, according to the Alzheimer’s Association[1]. Few pharmaceuticals have any noticeable effect on Alzheimer’s-related dementia and cognitive decline.