The FDA advisory panel which is composed of specialists who advise the FDA on brain medications, recently voted 6-0 in agreement on that the new drug, Leqembi, was effective in a recent study. FDA approval is expected to follow on or before July 6th.
The FDA is not obligated to follow the guidance of its advisors, yet it usually does.
The panel’s unanimous vote was based on clinical trial data confirming that Eisai (Leqembi) indeed benefits Alzheimer’s patients.
Further, the FDA will decide whether it should expand its earlier conditional approval into full approval.
If fully approved, more people will have access to Leqembi and similar Alzheimer’s medications as the FDA has indicated it will ease rules for reimbursement if Leqembi is awarded full approval.
Medicare’s standard for receiving coverage requires that treatment must be “reasonable and necessary”.
The conditional approval was influenced by a study with 850 participants. Results of the study indicated that Leqembi offered a benefit to Alzheimer’s patients.
In an effort to confirm the results of the first study, Biogen and Eisai conducted an 18-month trial. The results of this trial, which met its main goal, were available in September 2022 and showed that the rate of decline for the Alzheimer’s trial measured on a clinical dementia scale was 27% more slowly with Leqembi than with a placebo.
Various tests were used to analyze physical and mental function and the clinicians discovered positive data to support Leqembi’s efficacy.
Some doctors feel Leqembi is in a sense a victory where so many others have failed. Others think it only offers marginal benefits.
Panelists and Agency staff believe the study results are clinically meaningful.
In addition, there is the presence of ARIA side effects. ARIA is a side effect of drugs like Leqembi that can cause brain swelling and small brain bleeds.
One-fifth of the participants in the study group exhibited ARIA while 9% of the placebo group participants had the ARIA side effect.
Further, three people in an extension part of the study died. In this portion of the study, all participants were eligible to receive Leqembi.
Two of the aforementioned patients died as a result of brain bleeds while the third patient experienced a possible cerebrovascular accident together with severe ARIA.
Although the Agency reviewers did not overlook a possible link to Leqembi, the FDA is still not certain what role the drug played in the deaths.