Overview

• EMA’s Committee for Human Medicinal Products recommended market authorization for Donanemab as the EU’s second antibody therapy for early-stage Alzheimer’s.
• The European Commission will now review the CHMP’s advice before deciding if and when Donanemab can be marketed.
• Donanemab targets and clears amyloid plaques to slow disease progression by up to six months in patients with mild cognitive impairment.
• Treatment will be limited to roughly 10 percent of patients who meet genetic criteria of having no more than one ApoE4 allele.
• New conditions include MRI checks for vascular constrictions and administration by specialists with access to advanced imaging and multidisciplinary oversight.