Doctors, foundations welcome approval of Lakembi against Alzheimer’s disease
Doctors and Alzheimer’s foundations are applauding the change in position of an expert committee of the European Medicines Agency (EMA), which on Thursday revised its position and finally recommended marketing in the European Union of Lekembi (of which lekanemab is the active ingredient). It is the first drug to demonstrate clinical benefit against this disease, the leading cause of dementia in the world. Last July, the EMA rejected the same drug due to its complications.
Patient organizations, researchers and Alzheimer’s disease professionals in Spain welcomed the decision. Representatives of the Spanish Confederation against Alzheimer’s Disease and Other Dementias (CEAFA) called the EMA’s correction “very good news” that “avoids the discrimination” that European patients could be subjected to compared to other countries where the drug is already available. accessible.
The Spanish Society of Neurology (SEN) yesterday welcomed the EMA’s recommendation, “similar to that already made by the UK Medicines and Healthcare Products Regulatory Agency, which, in addition to placing restrictions on the use of this drug, excludes patients at higher risk of complications, e.g. in patients with two copies of the ApoE4 gene, it is emphasized that the medicine will only be available through a controlled access program,” explained Dr. Raquel Sánchez del Valle in a statement. Behavior and Dementia Coordinator, SEN Research Group. Lecanemab is planned to be administered intravenously twice a month.
The Spanish Agency for Medicines and Health Products (AEMPS) yesterday clarified that the pharmaceutical laboratory producing Lekembi must carry out a study of the registry of patients treated with the drug throughout the EU to determine the frequency and severity of possible adverse reactions associated with it. .
The Pascual Maragall Foundation and the ACE Alzheimer’s Center in Barcelona yesterday called the EMA’s recommendations “an important advance” that “opens a window of hope for patients and families living with Alzheimer’s disease.” Dr Merce Boada, creator of the ACE Alzheimer’s Centre, told Efe that this would be “the enormous progress we have been waiting for since the last Alzheimer’s drug was approved in 2003.”
Neurologist Pablo Martinez-Lage, scientific director of the CITA-Alzheimer Foundation, told SMC that the drug “reverses disease progression in people diagnosed with Alzheimer’s disease while they are still living a normal or near-normal life” and is intended “for humans only , in whom the disease is diagnosed very early,” he explained.