Eisai, Biogen Seek U.S. Approval for Potential Alzheimer's Drug
Tokyo, July 9 (Jiji Press)--Eisai Co. <4523> has announced that an application has been completed to gain approval from the U.S. Food and Drug Administration for aducanumab, a potential Alzheimer's drug jointly developed by the Japanese drugmaker and major U.S. biopharmaceutical firm Biogen.
"If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimers disease," the two companies said in a statement Wednesday.
The FDA is expected to decide whether to accept the application for review within 60 days. If the FDA gives priority to screening of the application, as asked by the two companies, the drug may be approved within six months, company officials said.
In clinical tests, Eisai and Biogen have confirmed a "statistically significant reduction of clinical decline" in patients treated with high doses of aducanumab, and a reduction in amyloid beta plaque in patients' brains.
[Copyright The Jiji Press, Ltd.]