With amyloid plaque reduction established as a surrogate endpoint by Aduhelm’s accelerated approval for Alzheimer’s disease, lecanemab is unlikely to face an advisory committee before its 6 January user fee goal date.
Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s disease treatment lecanemab should see smoother passage through the US Food and Drug Administration given the precedent set by the still-controversial accelerated approval of the companies’ Aduhelm (aducanumab-avwa) based upon the surrogate endpoint of amyloid plaque reduction.
The FDA has granted priority review to lecanemab, an anti-amyloid beta protofibril antibody, under the accelerated approval pathway and set...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
