US EditionLilly's Kisunla (Donanemab) Receives Marketing Authorization by European Commission for the Treatment of Early Symptomatic Alzheimer's Disease
The European Commission approved Kisunla to slow cognitive decline in early Alzheimer's patients, based on Phase 3 trials showing significant benefits for 1,736 participants.
- Recently, the European Commission authorized Kisunla for adults with early symptomatic Alzheimer's who have confirmed amyloid pathology and are ApoE4 heterozygotes or non-carriers.
- Clinical trial results and an urgent progression risk prompted the authorization, with TRAILBLAZER-ALZ 2 and 6 showing that gradual dosing reduced ARIA in early symptomatic Alzheimer's disease.
- The Phase 3 TRAILBLAZER-ALZ 2 study found Kisunla significantly slowed decline, with results published in the Journal of the American Medical Association , and Kisunla is given monthly via a 30-minute IV infusion.
- Health authorities warn about serious allergic and infusion-related reactions, requiring MRI brain scans and post-infusion monitoring of at least 30 minutes due to bleeding risks with antithrombotic medicines.
- As the first therapy enabling treatment completion when amyloid is minimal, donanemab could reduce infusion frequency and affect 6.9 million people in Europe with Alzheimer's.
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54 Articles
Eli Lilly Kisunla gets marketing authorization from European Commission for early symptomatic Alzheimer's disease
Indianapolis: Eli Lilly and Company has announced that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's...
The Berkshire Eagle
Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease
Approved for earliest symptomatic stages of disease, demonstrating significant slowing of cognitive and functional decline
The European Commission has approved the drug donanemab for the treatment of alzheimer in people with symptoms of mild cognitive impairment or mild dementia, as reported by the pharmaceutical company Eli Lilly. It is an antibody that removes beta-amyloid protein plates from the brain -one of the two main proteins involved in alzheimer along with tau- and has delayed disease progression in clinical trials.Keep reading...
Eli Lilly and Company has announced that the European Commission has approved the marketing of Kisunla® (donanemab).This medicine is indicated to treat adults with Alzheimer's disease in early stages, including those with mild cognitive impairment or mild dementia, provided they have confirmed amyloid plaques and are heterozygous or non-ApoE gene carriers."Donanemab has shown very positive results in patients with early Alzheimer's disease, as i…
Lilly secures EC approval for Kisunla to treat Alzheimer's disease
The approval applies to individuals with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers. Kisunla, administered as a monthly infusion, is already available in several The post Lilly secures EC approval for Kisunla to treat Alzheimer’s disease appeared first on Pharmaceutical Business review.
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