Eisai has achieved an important regulatory milestone as the FDA approves Leqembi IQLIK, strengthening the company’s long-term plans to expand the medicine’s use in Alzheimer’s treatment. It is a once-weekly subcutaneous maintenance dose, delivered through an autoinjector.
In alignment with its label as an intravenously infused formulation, Eisai’s Leqembi IQLIK is approved for patients living with mild cognitive impairment or mild dementia caused by Alzheimer’s. After completing 18 months of bi-weekly intravenous initiation therapy, patients may transition to the new subcutaneous maintenance dose, or continue with four-week infusion maintenance dosing, according to Eisai.
The approval of Eisai’s Leqembi IQLIK marks what could be a significant advance in Alzheimer’s therapy, according to Katsuya Haruna, senior group officer and executive vice president of U.S. business operations at Eisai. The company emphasized that the simplified injection format should make ongoing treatment easier for both patients and caregivers.
The FDA’s decision relied on findings from subcutaneous sub-studies within Eisai’s phase 3 Clarity AD open-label extension trial. The data showed that patients who switched to Eisai’s Leqembi IQLIK after 18 months of intravenous treatment maintained the same clinical and biomarker benefits as those who continued with IV dosing.
None of the patients receiving the autoinjector experienced local or systemic injection-related side effects. Only 1% reported reactions such as headache, fever, or fatigue, compared with up to 26% in those who received infused drug. Rates of amyloid-related imaging abnormalities (ARIA), a classwide concern with anti-amyloid drugs, were comparable between both treatment arms and consistent with background levels in untreated patients. Eisai noted that most ARIA incidents occur within the first six months of intravenous initiation therapy.
The regulatory nod also coincides with updated FDA guidance recommending earlier MRI monitoring for patients on Leqembi. The new protocol advises imaging prior to the third infusion to identify ARIA with edema more effectively, whereas the previous label required scans before the 5th, 7th, and 14th infusions.
With the FDA approving Leqembi IQLIK, Eisai has positioned itself to broaden patient access and streamline Alzheimer’s treatment. The company has announced that the autoinjector will be available in the U.S. beginning October 6.
Eisai confirmed a wholesale acquisition cost of $375 per autoinjector, equating to an annual list price of $19,500. The company explained that this pricing strategy balances broad patient access with the sustainability of the healthcare system, while reflecting the demonstrated societal value of subcutaneous administration.
