A handful of new products are under review at the European Medicines Agency. Orchard Therapeutics' gene therapy application will be fast-tracked; Roche's filing for its new flu treatment will not.
Orchard Therapeutics’ gene therapy for metachromatic leukodystrophy, OTL-200, and Roche’s new influenza drug, Xofluza (baloxavir marboxil), are among the new marketing authorization applications (MAAs) that have been accepted for review at the European Medicines Agency.
Other applications that are newly under assessment for potential approval throughout the EU include:
<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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