FDA accepts Eisai’s Leqembi sBLA for early AD treatment
Betsy Goodfellow | June 11, 2024 | News story | Medical Communications | Alzheimer's, Biogen, FDA, Neurology, sBLA
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted Eisai’s supplemental biologics license application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing.
A Prescription Drug User Fee Act (PDUFA) action date is currently set for 25 January 2025.
The drug is already indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease, collectively known as early AD.
According to the press release, ‘as part of the proposed monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury. The sBLA is based on modeling of observed data from the phase 2 study (Study 201) and its open-label extension (OLE) as well as the Clarity AD study (Study 301) and its OLE study’.
As well as this sBLA, Eisai has initiated the rolling submission of a BLA to the FDA for the subcutaneous autoinjector use of the drug for weekly maintenance therapy, following its fast track designation by the FDA in May 2024.
The drug is now approved in the US, Japan, China and South Korea, with applications having been submitted for review in the EU, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore and Switzerland.
Betsy Goodfellow
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