| Drug Name |
KISUNLA™ (donanemab-azbt) |
| Active Ingredient |
donanemab |
| Date of Approval |
July 2, 2024 |
| Manufacturer |
Eli Lilly and Company |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: KISUNLA™ is indicated for the treatment of Alzheimer’s disease. Treatment with KISUNLA™ should be
initiated in patients with mild cognitive impairment or mild dementia stage of disease. |
| Therapeutic Class |
Alzheimer Agent, Monoclonal Antibody |
| Formulation |
Injection: 350 mg/20 mL (17.5 mg/mL) in a single-dose vial |
| MoA |
Donanemab-azbt is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against insoluble Ntruncated pyroglutamate amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. Donanemab-azbt reduces amyloid beta plaques |
| Dosing and Administration |
The recommended dosage of KISUNLA™ is 700 mg administered as an intravenous infusion over approximately 30 minutes every four weeks for the first three doses, followed by 1400 mg every four weeks.
Dilution to a final concentration of 4 mg/mL to 10 mg/mL with 0.9% Sodium Chloride Injection, is required prior to administration.
Confirm the presence of amyloid beta pathology prior to initiating treatment. Consider stopping dosing with KISUNLA™ based on reduction of amyloid plaques to minimal levels on amyloid PET imaging. Obtain a recent baseline brain MRI prior to initiating treatment. Obtain an MRI prior to the 2nd, 3rd, 4th, and 7th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms. |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
According to the Alzheimer's Association, about 6.9 million (1 in 9) Americans 65 years and older have received a diagnosis of Alzheimer disease, 73% of whom are 75 years or older. Almost two-thirds of patients with Alzheimer are women, and Black Americans are twice as likely to develop Alzheimer disease or other dementias at some point in their lives compared with White Americans. The organization predicts that Alzheimer disease prevalence among people in the US will grow to 12.7 million by 2050.
KISUNLA™ is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions. This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease with the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients.
KISUNLA™ may cause amyloid-related imaging abnormalities (ARIA), detectable by MRI, presenting as brain swelling or bleeding. While usually mild, ARIA can be serious and life-threatening. It can also trigger severe allergic reactions during or shortly after infusion and commonly causes headaches. |
| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
The price of each vial of Kisunla is $695.65 |
| Product Discontinuation |
N/A |
| Clinical Trials |
The efficacy of KISUNLA™ in Alzheimer's disease was evaluated in a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) involving 1736 patients with confirmed amyloid pathology and mild cognitive impairment or mild dementia. Patients, aged 59 to 86 years with a Mini-Mental State Examination (MMSE) score of 20-28, were randomized 1:1 to receive either KISUNLA™ or placebo for up to 72 weeks. KISUNLA™ was administered as 700 mg every 4 weeks for the first 3 doses, followed by 1400 mg every 4 weeks, with the option to switch to placebo based on amyloid PET levels at specified intervals. Dose adjustments were allowed for treatment-emergent ARIA symptoms. The primary efficacy endpoint was the change in the integrated Alzheimer’s Disease Rating Scale (iADRS) score from baseline to 76 weeks, with secondary endpoints including the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB), ADAS-Cog13, and ADCS-iADL. Results showed a statistically significant reduction in clinical decline for KISUNLA compared to placebo in both the combined population (2.92, p<0.0001) and the low/medium tau population (3.25, p<0.0001) on the iADRS. Significant improvements were also observed in CDR-SB, ADAS-Cog13, and ADCS-iADL scores. The study highlighted a progressive eligibility for switch to placebo based on amyloid PET levels at Weeks 24, 52, and 76, with percentages of 17%, 47%, and 69%, respectively. The trial provided evidence of KISUNLA's efficacy over 76 weeks, although long-term benefits beyond this period remain uncertain. |
| |
Lilly’s KISUNLATM (Donanemab-azbt) Approved by FDA for the Treatment of Early Alzheimer’s Disease [news release]. Eli Lilly and Company. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early. Published June 26, 2024. Accessed July 3, 2024.
KISUNLA (donanemab-azbt) injection, for intravenous use [prescribing information]. Eli Lilly and Company. https://pi.lilly.com/us/kisunla-uspi.pdf?s=pi. Updated June 2024. Accessed July 3, 2024.
Stephens E. FDA Approves Donanemab for Early Alzheimer Disease. The American Journal of Managed Care. https://www.ajmc.com/view/fda-approves-donanemab-for-early-alzheimer-disease. Published June 26, 2024. Accessed July 3, 2024.
FDA Approves Lilly KISUNLA Treatment for Early Symptomatic Alzheimer Disease. Pharmaceutical Executive. https://www.pharmexec.com/view/fda-approves-lilly-kisunla-treatment-early-symptomatic-alzheimer-disease. Published June 26, 2024. Accessed July 3, 2024. |