Leqembi, after delay, gets back on track toward EU approval
Dive Brief:
- European drug reviewers have “reaffirmed” their positive view of Eisai and Biogen’s Alzheimer’s disease drug Leqembi, clearing the way for an approval decision by the European Commission, the companies said Friday.
- The recommendation from the European Medicines Agency followed a request by the EC to review new safety data that emerged after an EMA panel endorsed the drug in November. The committee chose not to change its stance after that evaluation.
- Clearance in Europe would open up use of Leqembi in the 30 countries of the European Economic Area, where around 22 million people have Alzheimer’s-related disability or dementia. It would also represent a comeback of sorts for Leqembi there, as the EMA initially rejected the drug before reversing course after the companies appealed.
Dive Insight:
Leqembi and Eli Lilly’s rival drug Kisunla modestly delay the progression of Alzheimer’s disease by removing a toxic protein called amyloid beta from the brains of people with the disorder. But both so do at the risk of what’s known as “ARIA,” a type of micro-bleeding or swelling in the brain.
The frequency of ARIA-related events in drug recipients has made Alzheimer’s doctors cautious about who should be treated with Leqembi and Kisunla. The EMA panel expressed similar concerns when it first rejected Leqembi last July, saying its ability to slow cognitive decline “does not counterbalance the risk of serious side effects.”
Eisai and Biogen appealed the ruling, beginning a process that, typically, doesn’t lead to a reversal. The companies succeeded, however, as the panel later agreed the risk of ARIA was low enough in people with a certain genetic profile to justify Leqembi’s use. People with no copies or one copy of the gene variant ApoE4 were at lower risk, while for those with two copies, who are more likely to have early-onset disease, the risk was deemed too high.
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