Eisai Files for Approval of New Alzheimer's Drug in Japan
Tokyo, Jan. 16 (Jiji Press)--Eisai Co. <4523> said Monday that it has applied for marketing authorization from Japan's Pharmaceuticals and Medical Devices Agency for a new Alzheimer's drug jointly developed with U.S. pharmaceutical company Biogen Inc.
Before submitting the application, the Japanese drugmaker utilized the PMDA's prior assessment consultation system to shorten the review period for the drug, lecanemab. The company aims to obtain marketing authorization by the end of this year.
The drug will actually be sold after the Japanese government sets the official price after approval.
Eisai has already filed for marketing authorization of the drug in the United States and Europe. In the United States, the drug will hit the market later this month after it was granted accelerated approval by the U.S. Food and Drug Administration on Jan. 6.
Lecanemab is designed for the treatment of patients in early stages of Alzheimer's disease, expected to slow the progression of symptoms by removing from the brain amyloid beta, a protein that is thought to trigger the disease.
[Copyright The Jiji Press, Ltd.]