The Alzheimer's drug lecanemab has not been approved by the European Medicines Agency (EMA). The benefits are not considered to outweigh the potential drawbacks.
A review of the decision will be requested, announces Swedish Bioarctic – whose stock plummeted on the news.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) believes that the observed effect of slowing down cognitive decline does not outweigh the risk of serious side effects associated with the medicine.
"This particularly concerns the frequent occurrence of amyloid-related imaging abnormalities, which include swelling and potential bleeding in the brain of patients who received the drug," the decision states.
Lecanemab, marketed under the brand name Leqembi, has been developed by the American pharmaceutical company Biogen and Japanese Eisai. The drug is based on a discovery by the Swedish pharmaceutical company Bioarctic, which holds a royalty on the global sales of lecanemab.
"We are surprised and very disappointed over CHMP's statement today," says Bioarctic's CEO Gunilla Osswald in a press release, and continues:
"However, this is not the final verdict, and our partner Eisai will request a review of CHMP's statement and continue working with authorities to ensure that the treatment becomes available to eligible individuals living with early Alzheimer's disease in the EU as soon as possible."
The drug has previously been approved in the USA, Japan, China, South Korea, Hong Kong, and Israel.
It is the EU Commission that ultimately makes the legally binding decision on marketing authorization for drugs. The decision is based on the European Medicines Agency's recommendation.
Alzheimer's is an incurable dementia disease. Approximately 100,000 Swedes, almost all over 65 years old, live with the disease, according to the Brain Foundation.
After the news, Bioarctic's stock plummeted, falling 34.3 percent on Friday.
Lecanemab is an antibody targeting a variant of a protein called beta-amyloid. Accumulations of beta-amyloid in the brain are believed by many researchers to cause Alzheimer's disease.
Earlier, several other antibodies targeting beta-amyloid have failed to slow down the disease progression. Lecanemab works by targeting a specific variant of the protein, so-called protofibrils, which researchers behind the drug believe are particularly harmful.
The drug is based on a discovery by Swedish researcher Lars Lannfeldt, professor at Uppsala University. His research group identified a change in the genetic material of a northern Swedish family severely affected by Alzheimer's disease.
The drug has been developed, among others, by the Swedish company Bioarctic, which Lars Lannfeldt co-founded.
Source: Uppsala University, Bioarctic
