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FDA approves Alzheimer’s drug lecanemab amid security situations

June 12, 2023: On Friday, A panel of independent people to the Food and Drug Administration meeting to recommend whether the Alzheimer’s drug Leqembi, created by Eisai and Biogen, should receive full approval.

The FDA is not required to follow the advisor’s recommendation, but a panel vote in favor of Leqembi would help pave the way for the treatment’streatment’s support this summer.

The FDA is expected to decide on Leqembi on July 6. The agency’sagency’s decision will determine whether Medicare broadly covers the treatment. The program for seniors is severely restricting coverage of Leqembi right now because it was approved through an expedited process.

Leqembi is the second Alzheimer’s treatment from Eisai and Biogen to come under FDA review after the controversial approval of Aduhelm in the summer of 2021.

The drug regulator granted expedited approval to Aduhelm, developed by the two companies, despite 10 of 11 advisory committee members concluding that the treatment did not indicate a clinical benefit. A congressional investigation subsequently found that the approval of Aduhelm was life with irregularities.

Eisai’s study of Leqembi found the drug slowed cognitive decline in early Alzheimer’s patients by 27%. The antibody is administered twice monthly through intravenous infusion. It targets a protein called amyloid, often named plaque, that builds up in the brain and is associated with the disease.

Dr. Teresa Buracchio, acting head of the FDA’s neuroscience office, told the panel that the instrument views these results as clinically meaningful for patients.

But Leqembi also harbors severe risks of brain swelling and bleeding. During the study, 13% of patients who received Leqembi had swelling, and 14% had bleeding.

The swelling and bleeding are typically mild without apparent symptoms, but these episodes can stand life-threatening, according to the FDA.

Three deaths in the study were possibly related to Leqembi, though the FDA could not draw explicit conclusions in its review.

Two patients who died suffered cerebral hemorrhages after receiving the infusions. They had been administered blood thinner medications. A third patient who died had an underlying condition named cerebral amyloid angiopathy, in which the blood vessels in the brain are weak, which can lead to bleeding.

Dr. Deniz Erten-Lyons, an FDA official, told the committee that taking blood thinners during therapy with Leqembi might increase the risk of cerebral hemorrhages.

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FDA approves Alzheimer’s drug lecanemab amid security situations