Biogen Secures Approval for At-Home Version of Alzheimer's Medication Leqembi

FDA Approval of Leqembi IQLIK

• New Subcutaneous Injection: The U.S. FDA has approved a subcutaneous injection version of Biogen and Eisai's Alzheimer's therapy, Leqembi, now branded as Leqembi IQLIK.
• Home Administration: A significant benefit of Leqembi IQLIK is that it allows patients to administer the treatment at home, contrasting with the previous requirement of receiving infusions at healthcare facilities.

Launch and Eligibility

• Launch Date: Biogen has announced that Leqembi IQLIK will be available starting October 6.
• Eligibility Criteria: The new version is only accessible to patients who have been on the infusion regimen for a minimum of 18 months, limiting immediate availability to a specific group of users.

Additional Context

• Monitoring Recommendations: The FDA has advised increased monitoring for Alzheimer's patients receiving Leqembi, indicating a focus on patient safety and treatment efficacy.
• Biogen's Financial Performance: Despite the approval, Biogen's recent financial results indicate ongoing challenges, particularly with its multiple sclerosis portfolio, as highlighted in their Q2 earnings call.