FDA to assessment eisai’s leqembi sbla sbla for alzheimer’s illness
Eisai and Biogen introduced that the US Meals and Drug Administration (FDA) has accepted for assessment the supplemental biologic drug advertising authorization utility (sBLA) submitted by the previous for Leqembi Iqlik’s subcutaneous autoinjector (SC-AI) (lecanemab-irmb) as a beginning dose for early Alzheimer’s illness.
The submission considerations sufferers with delicate cognitive impairment or delicate dementia as a result of Alzheimer’s illness.
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The FDA has set an motion date of Could 24, 2026 because the motion date for the Prescription Drug Person Price Act (PDUFA). If permitted, the Leqembi Iqlik 500 mg SC dosing routine, delivered as two 250 mg injections per week, would offer an alternative choice to the present biweekly intravenous (IV) administration.
This would offer care companions and sufferers the flexibility to provoke and preserve subcutaneous remedy at house (360 mg), offering flexibility between intravenous (IV) and SC routes throughout remedy.
The sBLA is supported by outcomes from a number of dosing research, together with the Part III Readability AD open-label extension substudies following an 18-month pivotal trial in people with early AD.
Outcomes indicated that 500 mg SC-AI as soon as weekly achieved publicity equal to biweekly IV dosing, with comparable scientific and biomarker advantages. The security profiles have been additionally comparable, with lower than 2% incidence of infusion reactions or systemic injection.
AD is characterised by amyloid beta (Aβ) and tau pathologies attributable to persistent protofibril neurotoxicity.
Leqembi at present has approval in 53 international locations and areas and is topic to regulatory oversight in seven different international locations.
In August 2025, the FDA permitted Leqembi Iqlik 360 mg for weekly subcutaneous upkeep following biweekly intravenous remedy for 18 months.
Eisai leads the worldwide improvement and submissions for lecanemab, with each corporations sharing business duties.
In November 2025, Eisai and Biogen introduced the UK Medicines and Healthcare merchandise Regulatory Company’s approval of Leqembi for IV upkeep dosing as soon as each 4 weeks to deal with early Alzheimer’s illness.
