Lecanemab, which is marketed under the brand name Leqembi, has been developed by the American pharmaceutical company Biogen and Japan’s Eisai and is based on a discovery by the Swedish pharmaceutical company Bioarctic.
Leqembi received so-called accelerated approval by the FDA earlier this year for patients with mild or early Alzheimer’s. The FDA has now reviewed more extensive studies before the drug received full approval.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” said Teresa Buracchio of the FDA in a statement.
With the FDA’s approval, it means that costs for the treatment are covered within the Medicare health care program, AP writes.
Medicare has blocked Leqembi and a similar drug, Aduhelm, pending full FDA approval.
Swedish Bioarctic holds a royalty on the global sale of lecanemab.