Amylyx’s Relyvrio survival data, drawn from a post hoc exploratory survival analysis of randomized patients, and the primary ALS functional endpoint ‘capture distinct concepts,’ FDA states. Use of long-term survival data from the same trial as confirmatory evidence was unusual, but not unique.
The US Food and Drug Administration’s approval of Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate/taurursodiol) has brought new focus to when the agency will accept confirmatory evidence to support approval on the basis of a single adequate and well-controlled trial.
In approving Relyvrio (previously known as AMX0035), the agency said data on an overall survival benefit can serve as confirmatory...
<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>
<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>
<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>
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<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>
