The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the Alzheimer’s drug Leqembi, which has been shown to slow the progression of the disease. This decision comes after the drug was previously rejected by the European Union.
Leqembi, containing the active ingredient lecanemab, is now the first Alzheimer’s treatment approved in the UK that has demonstrated effectiveness in delaying disease progression, according to an MHRA press release. Developed by the Japanese company Eisai and the American firm Biogen, Leqembi received approval in early 2023 in the United States for patients in the early stages of Alzheimer’s. It is also available in Japan and China.
However, the European Medicines Agency (EMA) decided in July not to approve Leqembi for use in the European Union. The EMA cited concerns that the risks of serious side effects, such as brain swelling and bleeding, outweighed the drug’s benefits. The MHRA acknowledged these risks, particularly for a specific group of patients with a certain genetic profile, representing about 15% of those diagnosed with Alzheimer’s. As a result, the drug was not approved for use in this subgroup.
The UK’s National Health Service (NHS) expressed reservations in an advisory report, stating that Leqembi’s benefits, which include slowing Alzheimer’s progression by four to six months, are not substantial enough to justify the significant costs. In addition to the high price of the drug, patients would need to visit the hospital every two weeks, with ongoing monitoring for potential side effects.
Alzheimer’s disease is the most common form of dementia, affecting more than 55 million people worldwide. Result reports that the mean survival time from Alzheimer’s disease diagnosis was 5.8 years.
