The FDA has announced the approval of the first drug to slow the decline of Alzheimer’s disease.
Leqembi proved to slow the mental decline. It is administered via intravenous infusion.
The U.S. Food and Drug Administration (FDA) has approved, for the first time, a drug to treat and slow the progression of Alzheimer’s Disease. Leqembi fights against the amyloid plaques, which build up in the brain and are a primary marker of the disease. The drug was approved as part of the FDA’s Accelerated Approval pathway, which approves drugs that help treat serious conditions.
A study was conducted with 1,795 Alzheimer’s disease patients, and those given Leqembi versus a placebo saw a significant slowing in mental decline over 18 months.
“On June 9, the FDA convened the Peripheral and Central Nervous System Drugs Advisory Committee to discuss whether Study 301 provided evidence of clinical benefit of Leqembi for the treatment of Alzheimer’s disease. All committee members voted affirmatively that the results of the study verified the clinical benefit of Leqembi for the indicated use,” wrote the FDA in a release.
Leqembi is administered via intravenous infusion every two weeks for one hour.