The US Food and Drug Administration has approved Biogen and Eisai's Alzheimer's drug, clearing way for at home treatment of the disease with injections administered by patients or a caregiver, the company said in a statement on July 13.
The drug regulator approved a supplemental Biologics License Application for a once-weekly initial dose of the drug named lecanemab-irmb subcutaneous injection ( LEQEMBI IQLIK) for the treatment of early Alzheimer's.
The injection is administered through an autoinjector and expected to be a convenient alternative to intravenous (IV) dosing primarily prescribed during the initial stage. To begin the treatment, the approved dosage is 500 mg given once weekly as two 250 mg injections, each delivered in approximately 15 seconds.
The drug may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment. Throughout the entire treatment course from initiation through maintenance patients may receive LEQEMBI either as IV infusion or as subcutaneous injection with LEQEMBI IQLIK.
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The injection is expected to be available by late August 2026 in the US. Patients can buy LEQEMBI IQLIK from a specialty pharmacy.
LEQEMBI is primarily prescribed for adults with mild cognitive impairment or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. Mild cognitive impairment is one of the earliest indications of Alzheimer's disease and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words.
“The approval of LEQEMBI IQLIK for initiation dosing marks a new era of Alzheimer's treatments," said Howard Fillit, MD, Co-Founder and Chief Science Officer Emeritus of the Alzheimer's Drug Discovery Foundation (ADDF). "For the first time, patients and their care partners have meaningful choice in how anti-amyloid treatment is delivered. As treatment approaches continue to expand, innovations in drug delivery will play a critical role in improving access to therapies, supporting the investigation of potential combination treatments, and advancing a precision medicine approach to Alzheimer's care.”
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