Anavex to request re-examination of CHMP opinion on MAAA for blarcamesine

Anavex (AVXL) Life Sciences provides a regulatory update on blarcamesine for early Alzheimer’s disease. The Company was informed by the Committee for Medicinal Products for Human Use of the European Medicines Agency of a negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine following its CHMP oral explanation. The CHMP is expected to adopt a formal opinion on the MAA at its December meeting. The Company intends to request a re-examination of the CHMP opinion upon its formal adoption, including providing relevant biomarker data, based on feedback and continued guidance from the CHMP, EMA and the Alzheimer’s disease community. The EMA procedures adopted by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first opinion. In addition, after initial dialogue, the U.S. FDA’s Center for Drug Evaluation and Research advised the Company to request a meeting to discuss the Company’s Alzheimer’s disease clinical trial results.