AVXL News & Events

Anavex Life Sciences announced its participation as a key industry partner in ACCESS-AD, a European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer's disease across real-world clinical settings. The five year program is funded by the European Commission's Innovative Health Initiative. "We are pleased that blarcamesine will be evaluated within ACCESS-AD's innovative precision-medicine framework," said Christopher U. Missling, PhD, President & CEO of Anavex. "This initiative represents a unique opportunity to integrate advanced biomarker data and digital tools with a therapy that is intentionally designed to be accessible, scalable and compatible within diverse healthcare environments. We look forward to contributing to a future in which personalised care is available to all people living with Alzheimer's disease."

Anavex Life Sciences (AVXL) announced the appointment of Wolfgang Liedtke, MD PhD, as Senior Vice President, Global Head of Neurology. Liedtke is a board-certified neurologist, who brings more than 25 years of extensive experience in developing and delivering innovative medicines in a broad range of CNS diseases, including genetic medicines and global therapeutic development. Most recently he was Chair of Neurology at Regeneron (REGN).

Anavex Life Sciences announced that the U.S. Food and Drug Administration had invited the Company to present the Company's Alzheimer's disease clinical trial results, reflecting the Agency's interest in the progress of Anavex's clinical development efforts. During the Type C meeting, the FDA shared their interest and collaborative approach to Anavex' development plans. The Company provided information related to the scientific rationale and profile of blarcamesine as an oral administration being convenient to dispense and the absence of significant safety concerns in clinical trials of blarcamesine conducted so far extending to the lack of amyloid-related imaging abnormalities. The meeting discussed the potential pathways to support an NDA for the treatment of Alzheimer's disease. In order to move forward, existing data from the Phase IIb/III ANAVEX2-73-AD-004 program requested by the Agency will be submitted. The Company committed to continue the initiated constructive exchange with the Agency in order to facilitate the timely evaluation and advance the Alzheimer's disease program.

Anavex Life Sciences announced that it has requested the European Medicines Agency, EMA, to re-examine its opinion on blarcamesine for the treatment of early Alzheimer's disease. Anavex has requested from the EMA the re-examination, and will work closely with the EMA during this process. The re-examination procedure is led by a different rapporteur and co-rapporteur, who will conduct a new evaluation of our marketing authorization application for blarcamesine. Anavex has also requested that the EMA consult a Scientific Advisory Group as part of this process to provide an independent recommendation.