The Food and Drug Administration granted traditional (full) approval to Leqembi, the Alzheimer’s treatment jointly developed by Biogen and Eisai, on July 6th.
In early June, external advisors to the FDA unanimously recommended Leqembi for full approval. The widely expected approval comes six months to the day after the FDA gave the drug a greenlight through its accelerated pathway program.
Leqembi’s initial launch has rolled out in strong fashion, complete with first recorded sales, prescription written and patient infusion over the past few months. The drug is on track to be a blockbuster, with one analysis projecting nearly $13 billion in global sales by 2028. This would be 17-times the sales total of Aricept, the second-longest approved Alzheimer’s drug.
