“We look forward to approval and launch there later this year.”

In context

“we might see more broadly across the total study population over time. This is a second positive Phase III trial to read out for pirtobrutinib as we continue to build evidence supporting the potential role for this medicine in earlier settings. We look forward to the readout of BRUIN CLL-313, which assesses pirtobrutinib versus chemoimmunotherapy in treatment-naive CLL/SLL later this year. We expect these data in combination with BRUIN CLL-314 to form the basis of regulatory submissions globally. In addition to our recent Phase III readouts, we also have updates on several other important molecules, donanemab, retatrutide and olomorasib. For donanemab, we had 3 important milestones since our last earnings call. First, we were pleased to receive a positive opinion from the CHMP in the EU. We look forward to approval and launch there later this year. Second, the modified dosing schedule was approved in the U.S., further strengthening the safety profile for donanemab, and we expect the modified dosing regimen to be part of the EU labeling at launch as well. Finally, we shared long-term extension data from TRAILBLAZER-ALZ 2, which demonstrated that, over 3 years, donanemab-treated participants showed increasing clinical benefit despite most participants having completed treatment within the first 18 months of the trial. In a separate part of the extension study, patients initiating donanemab after 18 months of placebo, also demonstrated disease slowing once they started donanemab. These data reinforce the value of early intervention and support the limited duration dosing approach with sustained and increasing long-term benefits for tre”