Eisai has started submitting data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in support of an application for approval of its investigational lecanemab (BAN2401) to treat early Alzheimer’s disease. This submission followed the company’s prior assessment consultation with the PMDA, given in advance of an approval application and intended to accelerate its review by identifying and addressing potential concerns, Eisai stated in a press release. Lecanemab is an investigational antibody, being co-developed with Biogen, given as an intravenous…
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