Anavex announces negative CHMP opinion on blarcamesine MAA

Anavex (AVXL) provided an update on the regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease. As per previous communication, the European Medicines Agency’s Committee for Medicinal Products for Human Use had informed Anavex about a negative trend-vote following its oral examination in November. As expected, the CHMP has adopted a negative opinion on the marketing authorization application, or MAA, for blarcamesine to treat Alzheimer’s disease. The company intends to request a re-examination of the CHMP opinion. 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. “We believe that the initiated dialogue reinforced our shared commitment to addressing the urgent unmet need in Alzheimer’s disease,” said Christopher Missling, president and CEO of Anavex. “Our team is committed to continue working in partnership with regulatory bodies in order to advance science and potentially new oral treatment options for patients and their families.”