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FDA approves Leqembi Iqlik as a weekly subcutaneous injection for Alzheimer's treatment, enhancing patient convenience and safety in care.
The once-a-week subcutaneous injection received approval for maintenance dosage for the treatment of Alzheimer’s.
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Biogen and Eisai announced that Leqembi Iqlik’s Biologics License Application (BLA) received approval from FDA as a once-a-week subcutaneous injection maintenance dose for the treatment of Alzheimer’s disease (AD). The BLA is based on Leqembi’s subcutaneous sub-studies of the Phase III clarity AD open-label-extension trial for patients suffering from early AD. The Phase III study evaluated the range of subcutaneous doses, with data reflecting after 18 months of 10mg intravenous (IV) treatment of Leqembi every two weeks that a weekly dosage of Leqembi maintains clinical and biomarker benefits, comparable to continued IV dosing,
Leqembi’s results from the Phase III Clarity AD open-label-extension trial, included 600 participants receiving a set range of dosage amounts, with 49 participants receiving a weekly dosage of 360 mg subcutaneous maintenance dose following 18 months of 10 mg doses every two weeks. Among the 49 participants, not one reported experiencing local or systemic-injection-related adverse events (AE).
The study also revealed across all subcutaneous doses that the safety profile was comparable to the IV treatment, with the only difference being systemic reactions occurring less frequently (1%) in subcutaneous doses, compared to IV infusions (26%).
Other study results showed an estimated 11% of participants experiencing reactions ranging from mild-to-moderate local reactions of redness, itchy injection site, and swelling. These reported reactions did not affect continued administration with less than 1% of participants reporting mild reactions such as headaches, ever, and fatigue.
Additionally, Aria rates in participants administered with the weekly 360 mg dosage were comparable to Aria rates in patients continuing with IV dosage after 18 months and show similar background rates of Aria as patients who never received an initial dose.
In order to confirm Leqembi Iqlik’s most efficient and safest use, additional studies were conducted, such as a human factors (HF) study along with a tolerability assessment of the injection device.
Patients who used the device noted the benefits, such as the ability to use the device at home, shortening treatment time, and continuing treatment without having to worry about visiting an infusion center. Healthcare providers also reported that the injection device has potential to provide an option for patients experiencing successful reactions to LEQEMBI and urges patients to continue treatment if successful.
The subcutaneous formulation of Leqembi Iqlik, also holds potential to reduce healthcare resources related to IV maintenance dosing, including preparation for infusion and nurse monitoring, increasing infusion capacity of new eligible patients beginning initiation treatment, and streamlining the AD treatment pathway.
Eisai offers several support programs for patients within the U.S. aimed to provide help and support for both patients and care givers. Eisai’s dedicated patient navigators offer support and guidance, working directly with patients and families to discover the correct treatment, as well as assist patients in understanding potential insurance coverage, co-pay amounts, and available patient access programs.
Along with support access to Leqembi for certain patients in need of help paying for their medicines, Eisai's Patient Assistance Program (PAP) offers Leqembi and Leqembi Iqlik at no cost for eligible uninsured and underinsured patients, including Medicare beneficiaries meeting financial and additional program criteria.1
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