United States: On Friday, regulators in Europe roadblock the approval for Biogen and Eisai’s Alzheimer’s therapy Leqembi, thus intensifying a problem that is already making it difficult for the companies to get this treatment approved in the United States.
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Leqembi’s approval ultimately lies in the European Commission, the European Union’s executive arm. Nevertheless, it tends to adhere to the drug regulator’s advice in virtually all cases.
In response to the regulator’s negative recommendation, Eisai announced it was “extremely disappointed.” The company further explained that it would try to seek a reexamination of the decision, as CNBC News reported.
Biogen’s share price also dropped by over 6 percent on Friday. However, Eisai Co., Ltd., a Japanese drug producer, remained almost unchanged.
FDA approved the drug last year
Last year, the US Food and Drug Administration gave the green light to Leqembi, which has received a slow start because of constraints connected with the diagnostic test and ordinary brain scans, among other things.
Leqembi has also obtained regulatory clearances in other countries, including Japan, South Korea, China, and Israel.
It was hailed as a cure for a progressive disease that is very difficult to manage, as the surrounding circumstances have shown. It is a monoclonal antibody with efficacy in halting the progression of the disease in patients in the early stages.
Reasons for not approving the drug
The European Medicines Agency’s human medicines committee decided not to provide marketing authorization to Leqembi.
The committee said that the effects of Leqembi’s regarding delaying cognitive decline do not outweigh “the risk of serious side effects associated with the medicine,” as the committee purportedly notes the “frequent occurrence” of brain swelling and bleeding in patients who received the treatment, as CNBC News reported.
Such side effects are traced to drugs such as Leqembi and another monoclonal antibody from Eli Lilly, Kisunla.
Kisunla functions by eradicating a toxic plaque known as amyloid in the brain, a common feature of Alzheimer’s disease. Kisunla got the nod in the US early this month.
Leqembi & Kisunla are landmarks in the treatment of Alzheimer’s after a trial of thirty years on efforts to develop drugs to combat the deadly ailment.
The second failed drug developed by Biogen in cooperation with Eisai, called Aduhelm, met difficulties in the US due to concerns over its approval and data. For 2021, the European Medicines Agency also rejected Aduhelm.