Vifor Pharma has resubmitted a marketing application for avacopan to the European Medicines Agency – this time for an unconditional approval.
Vifor Pharma is having another go at securing EU marketing approval for avacopan, its investigational treatment for ANCA-associated vasculitis, a group of rare kidney autoimmune diseases that lead to significant morbidity and mortality.
The Swiss company pulled its original application for a conditional marketing authorization (CMA) for avacopan nearly two years ago. It...
<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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