What's Happening?
Eisai Co. and Biogen Inc. have received FDA approval for a self-injected form of their Alzheimer’s drug, Leqembi, allowing patients to administer the treatment at home after completing initial infusions. The new formulation, Leqembi Iqlik, aims to simplify the treatment regimen and improve patient convenience. The drug, which targets amyloid protein in the brain, has been associated with side effects such as brain swelling and bleeding, necessitating multiple MRI scans during treatment.
Why It's Important?
The approval of a self-injected version of Leqembi could enhance patient adherence and accessibility, potentially increasing the drug's market reach. This development may also reduce healthcare costs associated with frequent medical visits for infusions. However, safety concerns remain, as the drug has been linked to serious side effects, prompting the FDA to recommend additional MRI screenings.
What's Next?
Eisai and Biogen plan to launch the self-injected formulation in October, with further regulatory submissions anticipated for additional indications. The companies are also developing a self-injected form for initial treatment, which could further streamline the regimen. Ongoing monitoring of safety and efficacy will be crucial as the drug becomes more widely used.
