Tag: European Medicines Agency

Regulatory Neuroscience News

European Commission Grants Marketing Authorization for Lilly’s Kisunla (donanemab) for the Treatment of Early Alzheimer’s Disease

Eli Lilly and Company

Eli Lilly and Company announced the European Commission has granted marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer’s disease. The therapy demonstrated a significant slowing of cognitive and functional decline and is unique for supporting a finite treatment course.

Clinical Trials Business News Regulatory Approval

Based on Results From the Phase 3 BRUIN CLL-321 trial, Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union

Eli Lilly and Company

The European Commission is currently taking final action on the application for the use of Jaypirca in patients with relapsed or refractory CLL who have received prior treatment with a BTK inhibitor as a result of this favorable view.