FDA Approves Home Injection Version of Alzheimer’s Drug Leqembi to Replace Hospital Infusions

The U.S. Food and Drug Administration (FDA) approved a new home injection form of the Alzheimer’s drug Leqembi (IQLIK) on Monday, allowing patients to self-administer the treatment instead of receiving intravenous infusions in medical centers. Previously, Leqembi was given via intravenous infusion over 18 months in hospitals worldwide, including in Israeli hospitals such as Ichilov, Sheba, and Rambam. In Israel, access to the drug has been limited to those who can afford private insurance or out-of-pocket payments, as it has not been included in the national health basket despite recent applications.

The newly approved injection is administered weekly via an automatic syringe and takes about 15 seconds, compared to the hour-long hospital infusions. The FDA’s approval was based on existing clinical trial data proving the intravenous form’s efficacy and pharmacokinetic data showing the subcutaneous injection achieves similar drug concentrations and amyloid beta plaque reduction in the brain. This approval was granted through the FDA’s Priority Review pathway, aimed at treatments for serious conditions with potential significant improvements.

Leqembi targets amyloid beta protein plaques in the brain, which are associated with Alzheimer’s disease progression. The disease affects over 6.5 million Americans, causing irreversible cognitive decline and loss of daily functioning. Common side effects include headaches, infusion-related reactions, and Amyloid-Related Imaging Abnormalities (ARIA), which can cause brain swelling or microbleeds detectable by MRI. Due to serious risks, the drug carries a "black box" warning, the FDA’s strongest safety alert. Genetic testing for the ApoE ε4 gene variant is required before treatment to assess ARIA risk, and caution is advised for patients on blood thinners due to increased bleeding risk.

Financial analysts predict the home injection form could increase Leqembi’s use by improving accessibility and differentiating it from competitors like Eli Lilly’s Kisunla, which requires hospital infusions only. However, challenges such as patient identification, accurate diagnosis, specialist availability, and insurance coverage remain barriers to widespread adoption. The Alzheimer’s Drug Discovery Foundation noted the approval may pave the way for combination therapies targeting multiple disease mechanisms beyond amyloid beta.

In summary, the FDA’s approval of Leqembi’s home injection form marks a significant shift in Alzheimer’s treatment delivery, potentially expanding patient access and convenience while maintaining safety and efficacy standards.