[Medicinal products in unauthorised indications]. / Rutinmässig off label-utvärdering bör inte göras av Läkemedelsverket.

ABSTRACT

The Medical Products Agency (MPA) has conducted the assessment presented in this manuscript within the remits of a Government assignment to the MPA. No new safety concern, and consequently no need for regulatory action, has been identified in relation to off-label use of rituximab in patients with active MS. While there is plausible pharmacodynamic, early phase clinical trial, and non-interventional data on effectiveness to support the biological effects of rituximab in MS, the magnitude of efficacy in relation to a well-defined population and posology has not been reliably confirmed from a regulatory perspective. From the MPA regulatory perspective, the benefit-risk balance for rituximab in patients with MS is at this stage considered undetermined. The overall recommendation of the MPA is to not create a specific procedure intended for systematically implemented benefit-risk evaluations of medicinal products in unauthorised indications.