Posted by Michael Wonder on 20 Jul 2018
Sanofi withdraws TGA submission for Kevzara
20 July 2018 - Outcome only made public after the publication of an AusPAR.
Sanofi sought to register sarilumab (Kevzara/Ilsidex) for use in combination with a non-biologic Disease-Modifying Anti-Rheumatic Drug (DMARD) for the treatment of moderate to severe rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to one or more DMARDs.
The dossier was accepted for evaluation on 29 January 2016. The submission was withdrawn by Sanofi on 26 April 2017 in consideration of its inability to submit additional efficacy data as part of the review process to further support the 200 mg dosing regimen.
