On Jan. 6, 2023, the U.S. Food and Drug Administration (FDA) gave Accelerated Approval to Leqembi™ (lecanemab-irmb – Eisai/Biogen) injection. By breaking apart amyloid beta plaques in the brain, it targets underlying protein deposits to treat Alzheimer’s disease. The recommended dosage is 10 mg/kg, administered as an intravenous (IV) infusion once every two weeks. Eisai plans a launch of Leqembi during or before the week of Jan. 23, 2023, exclusively through Soleo Health. The annual wholesale acquisition cost (WAC) will be about $26,500 for a patient who weighs 74kg (163 pounds). For complete prescribing information, look here.
u At a Glance
- Brand Drug: Leqembi (lecanemab-irmb)
- Manufacturer: Eisai and Biogen
- Date Approved: Jan. 6, 2023
- Indication: to treat Alzheimer’s disease
- Dosage Forms Available: Singe-dose 500mg/5mL and 200mg/2mL vials of solution for dilution and IV infusion
- Launch Date: It will be available during or before the week of Jan. 23, 2023.
- Estimated Annual Cost: Approximately $26,500 per year for a person of average weight (74kg)
- The most prevalent type of dementia, Alzheimer’s disease is estimated by the Alzheimer’s Association to affect about six million people in the United States and diagnoses are expected to double over the next 30 years.
- Although onset may be earlier for some individuals, Alzheimer’s disease symptoms generally begin around age 65 years with forgetfulness and trouble making decisions. Over several years, brain function gradually deteriorates — leading to increased cognition difficulties, behavioral changes, and physical symptoms. Patients in advanced stages are unable to care for themselves.
- For reasons that are not understood, Alzheimer’s disease is caused by abnormal protein deposits in the brain. Accumulations of proteins known as amyloid beta plaques, damage brain cells, and blood vessels. Tau proteins, which also build up in the brains of patients who have Alzheimer’s disease, twist nerve cells into distinctive “tangles”.
- Available drugs, such as donepezil and memantine, primarily relieve symptoms of Alzheimer’s disease.
- Prior to starting therapy with Leqembi, a recent brain MRI (within one year) should be evaluated for pre-existing amyloid-related imaging abnormalities (ARIA). After that, an MRI should be obtained before the fifth, seventh, and 14th infusions. If radiographic evidence of ARIA is observed, further recommendations are based on the type, severity, and presence or absence of symptoms to determine the best course of action.
- In a double-blind, placebo-controlled study of 856 patients with mild cognitive impairment or the mild dementia stage of Alzheimer’s disease, researchers found that treatment with lecanemab (10 mg/kg every two weeks) significantly reduced amyloid beta plaque in the brains of actively treated patients from baseline to week 79 compared to patients in the placebo arm.
- Aduhelm® (aducanumab-avwa – Biogen/Eisai) was the first amyloid beta monoclonal antibody to receive Accelerated Approval in June 2021 for treating Alzheimer’s disease.
- Lilly’s donanemab, another amyloid beta monoclonal antibody, also is under FDA review to treat Alzheimer’s disease. While the FDA action date has not been disclosed, a decision for Accelerated Approval is expected in early 2023.
- Under the terms of its Accelerated Approval policy, the FDA requires additional clinical study results to prove that Leqembi actually provides a clinical benefit for treating Alzheimer’s disease.
- Eisai recently published early data from their large global confirmatory Phase 3 clinical trial, called Clarity AD. The company plans to file a Supplemental Biologics License Application (sBLA) with the FDA for formal (traditional) approval. If traditional FDA approval is granted later this year, it could trigger coverage by Medicare.