Eisai and Biogen have initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a subcutaneous version of their Alzheimer's drug, Leqembi. This new formulation aims to provide patients with an injectable option via an autoinjector, transitioning from the current infusion method to weekly injections. The submission is under the Fast Track status, which is intended to expedite the review process for drugs that address unmet medical needs. The rolling application was previously delayed by the FDA on procedural grounds.
Eisai to offer Alzheimer's drug in China from July https://t.co/pPj0IeOUPt
Eisai sets new revenue target for Alzheimer’s drug Leqembi https://t.co/K1Q8hqaAgK $ESAIY $BIIB by @realJacobBell
Eisai sets new revenue target for #Alzheimers drug Leqembi https://t.co/ulxh0aROHM by @realJacobBell $ESALY $BIIB
Eisai and Biogen applied with the FDA to sell Alzheimer’s drug Leqembi through an autoinjector, which would allow patients to transition into weekly injections. Currently, patients need to receive infusions… https://t.co/mNlCcEOano
Along with @EisaiUS, we’ve initiated the rolling submission of a Biologics License Application to the U.S. #FDA for the investigational subcutaneous formulation of our drug for early #AlzheimersDisease. Learn more about this #news: https://t.co/h3TU79jrzP https://t.co/UgXPQEUhRd
. @EisaiUS and @Biogen have filed a rolling application in the US for a subcutaneous version of #Alzheimers therapy Leqembi that was delayed by the FDA on procedural grounds. https://t.co/vCmkHAkcT9 https://t.co/GRyCWGKECM
Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA https://t.co/mRcmgDGpIJ https://t.co/03wgZtD9TN
Eisai Starts Rolling Submission for Injectable Version of Alzheimer’s Drug with US FDA https://t.co/HWVCZhHobM
$BIIB Eisai Initiates Rolling BLA for LEQEMBI for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status.