The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued, after months of reviews, the recommendation of market lecanemabthe first drug to demonstrate clinical benefits in Alzheimer’s disease, for the treatment of mild cognitive impairment or mild dementia in patients who have only one or no copies of ApoE4.
This decision is made after having rejected last July the authorization of the same drug, marketed as ‘Leqembi’ by Eisai and Biogen, due to its side effects in a broader population of people with early-stage Alzheimer’s disease. Likewise, the EMA points out that the drug will be available through a controlled access program to guarantee that the drug is only used in recommended patients.
The decision made this Thursday affects patients with a single copy of ApoE4 or without it, who are less likely to experience amyloid-related imaging abnormalities (ARIA) than people with two copies. ARIA is a recognized serious side effect of ‘Leqembi’ involving swelling and possible bleeding in the brain.
The US Food and Drug Administration (FDA) granted traditional approval to lecanemab in July 2023following unanimous endorsement of its clinical efficacy by an advisory committee. In the North American country, it was agreed to provide broad coverage for this drug for eligible patients with early-stage Alzheimer’s. It was also authorized in an early phase by the regulatory authorities of Japan on September 25, 2023, and this year by those of China (January 3), South Korea (May 27), Hong Kong (July 11) and Israel (July 12).
For the re-examination, the company provided a subgroup analysis of data from the main study that included 1,521 patients who have one or no copies of ApoE4 out of a total of 1,795 patients. The main measure of effectiveness was a change in cognitive and functional symptoms after 18 months, measured with a dementia rating scale known as CDR-SB and ranging from 0 to 18, with higher scores indicating greater deterioration.
After 18 months of treatment, patients treated with ‘Leqembi’ had a minor increase in CDR-SB score than those who received placebo (1.22 vs. 1.75), indicating slower cognitive decline. Results for other key measures were similar to those observed with that scale.
As with all evaluations, during the re-examination the CHMP also considered submissions from patients, caregivers, doctors and organizationswho shared their perspectives on the unmet needs of patients with Alzheimer’s disease and data on cognitive decline and risks.
The CHMP opinion is an intermediate step on the ‘Leqembi’ path towards patient access. The opinion will now be sent to the European Commission for a decision on a marketing authorization at EU level.
Once a marketing authorization has been granted, decisions on pricing and reimbursement will be made. in each Member Statetaking into account the potential role and use of this medicine in the context of its national healthcare system.
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