sNDA Granted to Ticagrelor, BAN2401 Phase 3 Trial Launched, Telemedicine Reimbursement Set to Expire

This week Neurology News Network covered the supplemental new drug application for ticagrelor for those who experienced an acute ischemic stroke or transient ischemic attack, the launch of the phase 3 trial of BAN2401, and the recent expirations of telemedicine reimbursement.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

AstraZeneca has announced that the FDA has accepted a supplemental new drug application, and granted a priority review designation, for ticagrelor for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack. The Prescription Drug User Fee Act date for this supplemental application is scheduled for the fourth quarter of 2020. The basis of the decision comes from results of the phase 3 THALES trial, in which the treatment met its primary end point, reducing the risk of composite of stroke and death after an AIS or TIA. The results of the study were in line with the known safety profile of ticagrelor. Ticagrelor was first approved by the FDA as a blood-thinning agent in 2011 and again in September 2015 as an oral 60-mg tablet for an expanded indication for the reduction of cardiovascular risk in patients with a history of cardiovascular disease.

Eisai and Biogen, in conjunction with the Alzheimer’s Clinical Trials Consortium, have announced the launch of a phase 3 clinical study of the investigational Alzheimer disease agent BAN2401, to assess the therapy in those with preclinical Alzheimer disease. Dubbed AHEAD 3-45, the study is a public-private partnership between the ACTC and Eisai, and is funded by the National Institute on Aging. It will be conducted at sites in the US, Japan, Canada, Australia, Singapore, and Europe, and aims to enroll 1400 participants who will be treated with BAN2401 for 216 weeks. A common screening period will be conducted, after which patients will be randomized to 1 of 2 trials: A3 and A45.

As many states across the US experience a resurgence in COVID-19 infections, many of the health care and insurance policies for telemedicine reimbursement that were enacted under the Department of Health CARES Act waiver have begun to expire. As of June 1, 2020, several commercial payers have reduced or stopped service and payment parity policies for telehealth despite an unprecedented level of interest and participation in telemedicine care among health care providers and patients. The need to have continued access to telemedicine is particularly relevant in the neurology sphere, where vulnerable patient populations who require routine follow-up can be spared additional exposure in a health care practice or hospital setting by connecting with their provider via video teleconference or phone. As such, a number of neurology organizations have come together under the leadership of the Women Neurologist Group and The Alliance for Advancement of Neuroscience to petition legislative representatives to support the continued use of telemedicine with service and payment parity across all 50 states and the District of Columbia.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.