The withdrawal of the EU filing for abicipar pegol will fuel speculation that Allergan parent AbbVie is indeed ditching the potential treatment for wet AMD. US regulators have already said they won't approve the drug.
Allergan plc has formally withdrawn its marketing authorization application (MAA) for abicipar pegol from the European Medicines Agency, less than a month after US regulators said they would not approve the potential treatment for neovascular (wet) age-related macular degeneration.
The withdrawal of the MAA is noted in the agenda for the July meeting of the EMA’s drug evaluation...
<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>
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.
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