First disease modifying therapy for primary progressive MS in Europe

European Medicines Agency (EMA) committee recommends granting a marketing authorisation for ocrelizumab for people with primary progressive MS or relapsing remitting MS

First Disease-Modifying Therapy for Primary Progressive MS in Europe

14 December 2017

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for ocrelizumab for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).

The opinion adopted by the CHMP at its November 2017 meeting is a key step on ocrelizumab’s path to patient access in the European Union. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, considering the potential role/use of this medicine in the context of the national health system of that country.

The positive opinion by CHMP is a critical step in ensuring that an additional treatment option for patients with RMS and is the first medicine in the EU intended to treat some patients with PPMS. This follows the approval of ocrelizumab in the United States, Australia and Switzerland.

“We are encouraged with the continued focus of the regulatory agencies and progress being made to bring forth treatments for this disabling form of MS. One cannot under-estimate the importance and impact of the very first treatment for primary progressive MS – this is the crucial first step in finding ever more effective treatments for everyone with progressive MS,” noted Prof. Alan Thompson, Chair of the Alliance’s Scientific Steering Committee and Dean of University College London Faculty of Brain Sciences.

The Alliance continues to assess all potential areas of progress and increased understanding, while bringing the world together to accelerate the development of treatment for everyone living with progressive MS.

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