London –
The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval of sales of lecanemab to treat Alzheimer’s disease.
The committee of the pharmaceuticals watchdog had shown a negative opinion in July on the medicine, developed by drugmakers Eisai of Japan and Biogen of the United States.
After conducting a reexamination as requested by the pair, however, the committee judged that the efficacy of the medicine outweighs the risk for some patients.
If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer’s medicine available in the European Union region.
According to the EMA, the recommendation excludes patients who carry two copies of the ApoE4 gene, considering the higher risk of side effects such as swelling and bleeding in the brain.
Lecanemab is sold in Japan, China and the United States. Britain gave it sales approval in August.