“We maintain conviction that given the impact of this devastating disease and significant unmet need, positive confirmatory data and FDA traditional approval should be sufficient to support global reimbursement and patient access necessary for broad use of donanemab over time.”

In context

“se letter for accelerated approval of donanemab due to the limited number of patients with at least 12 months of drug exposure. There were no other deficiencies cited. We will continue to work with the FDA to evaluate the best pathway to make this potential treatment option available to patients and look forward to results next quarter for the TRAILBLAZER-ALZ 2 Phase III confirmatory trial, which will form the basis of donanemab's application for traditional approval. We have consistently stated that, we would expect very limited uptake before CMS supports coverage. At the time we submitted for accelerated approval, we had hoped that there would be more movement from CMS to provide access to these medicines for people with Alzheimer's disease. Unfortunately, this has not yet materialized. We maintain conviction that given the impact of this devastating disease and significant unmet need, positive confirmatory data and FDA traditional approval should be sufficient to support global reimbursement and patient access necessary for broad use of donanemab over time. Also in the month of January, we received FDA approval for Jaypirca, the first and only non-covalent BTK inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor. Jaypirca is a highly selective kinase inhibitor, is novel reversible binding mechanism and pharmacology may allow for extended targeting of the BTK pathway, following treatment with a covalent BTK inhibitor. We are pleased with the recent approval of Jaypirca and we remain confident in the long-term opportunity for donanemab. We also look forward to the potential launch of two of our immunology assets later this year with mirikizumab and lebrikizumab and of tirzepatide for obesity. This current wave of new launches along with the ongoing focus”