Ocrelizumab Receives Licence in EU

Roche’s ocrelizumab receives licence in the EU for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)

Ocrelizumab is first and only approved disease-modifying medicine for people in EU with early PPMS

Dublin, 12 January 2018: Roche announced today that ocrelizumab has been granted marketing authorisation in Europe for patients with certain types of active relapsing forms of multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS). Ocrelizumab is the first and only approved disease-modifying medicine for people in the European Union (EU) with early PPMS. Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form.1,2 Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.3 

“An estimated 1,350 people in Ireland live with PPMS. Today’s licence of ocrelizumab signifies an important treatment option for their disease,’’ said Dr Michal Starnawski, Roche’s Medical Director in Ireland. “Ocrelizumab is the first medicine to be approved for primary progressive MS, a debilitating form in which patients can quickly start to experience disability that is irreversible.  Now that we have the licence, we can move forward to the next stage of ensuring access for patients. We are committed to working with the HSE to provide this access as quickly as possible.’’

Speaking about the new licence, Professor Chris McGuigan, Consultant Neurologist at St. Vincent's Hospital in Dublin said “The granting of an EU licence for ocrelizumab is very positive news. Currently, there are no other licensed drugs for this type of MS and people with the condition experience a progression in symptoms which can cause mobility issues making work and daily activities challenging.” 

The most common side effects associated with Ocrelizumab in all Phase III clinical trials were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.  

About Ocrelizumab   

Ocrelizumab is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with multiple sclerosis (MS). Based on preclinical studies, Ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved. Ocrelizumab is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.