The FDA granted full approval to Leqembi (lecanemab) July 6, six months after handing Eisai and Biogen's Alzheimer's drug an accelerated approval.
In February, CMS said it would not cover Leqembi until the agency gave it full approval; accelerated approvals are based on a marker that predicts clinical benefit rather than a measure proving clinical benefit. Researchers at University of California, Los Angeles found Leqembi could cost Medicare an estimated $2 billion to $5 billion annually.
The Department of Veterans Affairs has been covering the amyloid-targeting medication, which costs $26,500 for a year's supply, since March.
Leqembi is approved to treat patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology, the FDA said in a news release.
The monoclonal antibody, which is intended to be infused every two weeks, is the third drug to be approved to treat Alzheimer's since 1993, according to the Alzheimer's Association. It's also the first fully approved Alzheimer's drug.
"The Food and Drug Administration's full approval of lecanemab provides much needed new hope in the fight against Alzheimer's disease," said Chuang-Kuo Wu, MD, director of Rhode Island Hospital's Alzheimer's Disease & Memory Disorders Center, one of the participating sites for the lecanemab study. "We are pleased with the FDA's decision."
In a phase 3 trial of about 1,800 people, the drug slowed cognitive decline by 27 percent. Three patients died during the trial, and both of the drug's sponsors said the fatalities were not related to the medication.
The patient deaths were connected to amyloid-related imaging abnormalities, which includes hemorrhages. The rate of ARIA events in the trial was 12.5 percent.