Subcutaneous ocrelizumab approved in EU for relapsing MS and PPMS
The European Commission has approved a subcutaneous formulation of ocrelizumab to treat adults with MS.
The approval makes the new formulation available in the European Union for the same indications as the original intravenous formulation, which is available to people with relapsing forms of MS with active disease as well as primary progressive MS.
The decision brings an easier-to-administer formulation of the CD20 inhibitor to MS patients in Europe; while the original formulation is given via a two- to four-hour infusion, the newly approved version can be given via an under-the-skin injection administered by a healthcare professional that takes 10 minutes.
The new formulation was tested in the Phase 3 OCARINA II trial, which compared its safety, efficacy, and pharmacological properties to those of intravenous ocrelizumab in 236 adults with relapsing forms of MS and PPMS.
