Eisai, Biogen apply for approval of Alzheimer’s drug

Tokyo, The Gulf Observer: Japanese pharmaceutical firm Eisai on Monday said it has applied to Japan’s health ministry for approval of its Alzheimer’s drug. Eisai developed lecanemab with US partner Biogen.

The drug is designed to slow the progression of the neurodegenerative disease by reducing the accumulation of amyloid beta in the brains of Alzheimer’s patients. The abnormal protein is believed to induce neuronal cell death.

The drug utilizes an antibody that binds to the protein and removes it.

Eisai says the drug reduced the rate of cognitive decline in patients by 27 percent compared to a placebo in an 18-month clinical trial.

The drug reportedly increased risks of brain swelling and bleeding. But Eisai says there was no difference in the rate of death between patients on lecanemab and the placebo group during the trial.

The US Food and Drug Administration granted lecanemab fast-track approval as an Alzheimer’s drug on January 6.

Eisai says it hopes to receive authorization of the drug in Japan by the end of this year.