The FDA approved a drug on Friday designed to slow cognitive decline in patients with Alzheimer's disease.
The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report for approving another Alzheimer's drug, Aduhelm.
The trial results showed that the treatment can cause brain swelling and bleeding.
The FDA fast-tracks approval of drugs for serious conditions where there is an unmet medical need.
The FDA said that Leqembi and Aduhelm were an important advancement in the fight against Alzheimer's disease.
Billy Dunn of the FDA's Center for Drug Evaluation and Research said in a statement thatAlzheimer's disease is incapacitating the lives of those who suffer from it and has devastating effects on their loved ones.
The latest therapy to target and affect the underlying disease process of Alzheimer's is called Leqembi.
According to the Alzheimer's Association, approximately 6.5 million Americans suffer from the disease.
The data from the trial showed that it slowed cognitive decline in Alzheimer's patients by 27 percent.
The trial involved almost 1800 people who were divided into two groups, one given the drug and the other a placebo.
The incidence of brain bleeds and swelling was raised in the complete trial data.
The results showed that patients who received the drug had a higher incidence of brain bleeds than those who did not.
The group that took the drug experienced brain swelling at a higher rate than the group that took the placebo.
The trial of the drug resulted in the same number of deaths.
Alzheimer's disease is caused by the build up of tangles and plaques in the brain.
Leqembi is used to target amyloid.
Patients who received Leqembi had a statistically significant reduction in brain amyloid plaque compared to the placebo group.
There was controversy over whether Aduhelm worked and three high-level resignations in the FDA after it was approved for use.
The accelerated approval process for Aduhelm, the first drug to treat Alzheimer's in decades, was criticized by a congressional investigation.
The congressional report said that the price for Aduhelm was "unjustifiably high."
100,000 Americans could receive Leqembi by three years from now, according to the estimates of the company.
The president and CEO of the Alzheimer's Association welcomed the approval of Leqembi but expressed concern that its high cost could put it out of reach for most Americans.
People with this fatal disease don't have time to wait for a miracle drug or cure.
Agence France- Presse.
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