Biogen and Eisai have announced that the Japanese drugmaker has initiated a rolling Biologics License Application with the US Food and Drug Administration (FDA) for a subcutaneous (SC) version of their Alzheimer’s disease drug.
Leqembi (lecanemab-irmb) was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage Alzheimer’s disease.
The Leqembi SC autoinjector has already been granted Fast Track designation by the regulator and is under review for weekly maintenance dosing in patients who have completed the bi-weekly IV initiation phase.
If approved, the autoinjector could be used to administer the drug at home or at medical facilities, with the injection process requiring less time than the IV formulation.
“This SC autoinjector is easier for patients and their care partners to use and may reduce the need for hospital visits and nursing care compared to IV administration,” the companies said in a statement.
Affecting more than 6.5 million Americans, Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
The FDA’s decision to grant full approval to IV Leqembi was supported by data from the phase 3 confirmatory Clarity AD clinical trial, in which the drug reduced clinical decline by 27% on the global cognitive and functional scale compared with placebo at 18 months.
All multiplicity-controlled secondary endpoints also showed highly statistically significant results compared with placebo, including other measures of cognition and daily function.
Eisai, which serves as the lead for the drug’s development and regulatory submissions globally, presented positive results from an open-label extension of Clarity AD in October.
The SC sub-study included 72 patients who received Leqembi for the first time as the SC formulation and 322 patients who received the drug’s IV form in the Clarity AD core study followed by SC administration.
The results presented at the Clinical Trials on Alzheimer’s Disease conference showed that weekly SC administration of Leqembi removed 14% more amyloid plaque than the approved IV formulation after six months of treatment. Blood concentration levels of the drug were also 11% higher with SC Leqembi than with the IV version.