Anavex receives CHMP agreement for MAA submission on oral blarcamesine

Anavex Life Sciences announced today that the Committee for Medicinal Products for Human Use within the European Medicines Agency agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure. The granting of the eligibility from the CHMP under the centralised procedure allows for submission of a single Marketing Application to the European Medicines Agency that, if approved, would allow blarcamesine to be marketed in all EU member states. Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024. The ANAVEX 2-73-AD-004 Alzheimer’s disease placebo-controlled Phase 2b/3 trial showed that in addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration. Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized, placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal.