“These data certainly reinforce our confidence in donanemab and the forthcoming readout from our Phase III TRAILBLAZER-ALZ 2 study, which is expected by the middle of 2023, and which, if positive, will form the basis of our application for traditional regulatory approval.”

In context

“gene therapy approach to treating genetically defined hearing loss. Hearing loss is an area of severe unmet need that historically has not been a focus of pharmacologic development. And we believe treatment of sensory neuronal hearing loss through gene therapy delivered to the inner ear is an area ripe for technologic advances for the benefit of patients. Finally, let me turn to Alzheimer's disease, where there have been a number of important developments since our last call. As a company dedicated to the fight against Alzheimer's, we were pleased to see the positive top line Phase III results for lecanemab. Following dunetimab's TRAILBLAZER-ALZ study, this lecanumab study may further support the benefit of removing amyloid plaques for people with early symptomatic Alzheimer's disease. These data certainly reinforce our confidence in donanemab and the forthcoming readout from our Phase III TRAILBLAZER-ALZ 2 study, which is expected by the middle of 2023, and which, if positive, will form the basis of our application for traditional regulatory approval. In the meantime, we continue working with the FDA to seek accelerated approval in early '23 and based on our TRAILBLAZER-ALZ data. The availability of and access to safe and effective therapies is important to slow the devastating impact on the estimated 6.5 million Americans and 35 million people worldwide living with this disease and their loved ones. While we acknowledge the hard work ahead to bring these therapies to patients in need, we are excited and we are confident in our Alzheimer's disease portfolio and the potential impact our drugs can have on patients. Accordingly, we initiated TRAILRUNNER-ALZ, the first trial in our Phase III program for Remternetug, our next-generation anti-amyloid antibody. Remternetug has demonstrated deep and rapid amyloid plaque clearance and provide”