Eisai and its U.S. partner Biogen said on August 24, 2026, that Leqembi Iqlik, the subcutaneous autoinjector formulation of the Alzheimer's drug lecanemab-irmb, is now available in the United States for patients starting treatment, not only for those already on maintenance dosing. The launch follows the Food and Drug Administration's July 13, 2026 approval of the autoinjector as an initiation option: 500 mg given once weekly as two 250 mg injections, each administered in about 15 seconds, according to Biogen's own announcement of that approval. Before this year, the at-home injector was cleared only for maintenance dosing, available since 2025 after 18 months of infusions.
Under the newly available regimen, a patient can now begin lecanemab entirely by injection, whether given at home or in a clinic, moving to a maintenance dose of 360 mg once weekly after 18 months of either intravenous or subcutaneous treatment, per the companies' description of the approved regimen. That removes the requirement, in place since the drug's original approval, that every patient begin with biweekly IV infusions before any switch to injections could occur.
On September 3, 2026, Eisai and Biogen announced that China's National Medical Products Administration had approved the same subcutaneous formulation as an initiation treatment for mild cognitive impairment or mild dementia due to Alzheimer's disease, the companies said in a joint release. The Chinese application was accepted in January 2026 and granted priority review; the companies said launch is planned within Eisai's fiscal year, which runs through March 2027. Lecanemab is now approved in 53 countries and regions, according to Biogen's July release, though the initiation-dose injector itself is so far cleared only in the United States and China.
The regulatory clearances in both countries rested on a data package comparing the injector's pharmacokinetics and safety to the already-approved intravenous drug, which Eisai presented at the Alzheimer's Association International Conference on July 13, 2026, describing it as showing similar efficacy and safety to the IV formulation. That is a bridging comparison, not a new randomized trial measuring the drug's effect on cognitive decline; the clinical evidence that lecanemab slows progression in early Alzheimer's disease still comes from the original Clarity AD trial of the intravenous drug.