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Home  /  Activities   /  EUnetHTA Joint Action 3 (2016 - 2020)   /  PTJA08 – Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity

PTJA08 – Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity

This is the pharmaceutical Joint Assessment PTJA08 – on siponimod for the treatment of active SPMS. In January 2020, the European Commission granted marketing authorisation for Mayzent® (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. This Joint Assessment aims to compare the clinical effectiveness and safety of siponimod in the target patient populations with relevant comparators according to the national requirements of EUnetHTA partners.

Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by Novartis) and by Novartis, the Marketing Authorisation Holder of siponimod (PTJA08 submission dossier).

For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl

PTJA08 – Final Project Plan

PTJA08 – Final Assessment report

PTJA08 – MAH Core Submission Dossier

PTJA08 – External Comments – Factual Accuracy Check MAH