The European Medicines Agency (EMA) has rejected a license for an Alzheimer’s treatment that has shown promising results in slowing cognitive decline. The drug, lecanemab, was found to slow cognitive decline by about a quarter in patients in the early stages of Alzheimer’s, making it a potential breakthrough in the field.
However, the EMA cited safety concerns as the reason for rejecting the license, stating that the benefits of the treatment did not outweigh the risks of serious side effects, such as bleeding and swelling in the brain. Despite this setback, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still considering whether to grant a license for the drug.
Alzheimer’s researchers have hailed the trial results as historic, as lecanemab works by clearing a rogue protein called amyloid, which builds up in the brains of Alzheimer’s patients. If approved in the UK, health bodies will then have to decide whether the drug represents value for money and should be recommended to patients.
Although the decision by the EMA may be disappointing to many, experts remain hopeful for the future of Alzheimer’s treatment. With ongoing research and clinical trials, there is optimism that new and safer treatments will be discovered in the near future. The rejection of lecanemab may lead to unintended consequences, such as wealthy individuals seeking treatment in other jurisdictions where the drug is approved.
Overall, the rejection of lecanemab by the EMA marks an important moment in the search for effective Alzheimer’s treatments. With 164 active clinical trials for the disease currently underway, there is hope for more treatments to be submitted for approval in the future. Despite this setback, the Alzheimer’s Society remains optimistic about the future of Alzheimer’s research and treatment.
