Ocrelizumab has been approved as the first licensed treatment for some people with primary progressive MS in the UK.
Recently recommended by the European Medicines Agency (EMA), today the European Commission approved the licence.
UK regulators will now decide whether ocrelizumab should be available on the NHS.
The conditions of the licence mean ocrelizumab (brand name Ocrevus) can only be prescribed for people with early primary progressive MS. This means:
people who have evidence of inflammatory activity identified through an MRI scan
Other factors that will be taken in consideration are:
In the trials used by the EMA to assess ocrelizumab for a licence, participants had MS symptoms for 15 years or less, and EDSS scores of 3.0 to 6.5. But those criteria aren’t defined in the licence. So if you think you could benefit from ocrelizumab, you should talk to your neurologist. There’s no age limit on who can be prescribed it.
Ocrelizumab has also been licensed for everyone with relapsing MS.
In the latest trials, ocrelizumab slowed progression in primary progressive MS compared to a placebo (dummy) drug. It also reduced relapses and MRI activity and slowed progression in relapsing MS compared to beta interferons.
The National Institute for Health and Care Excellence (NICE) will now decide whether ocrelizumab should be available on the NHS in England and Wales. Northern Ireland will decide whether or not to adopt the NICE decision shortly afterwards.
The Scottish Medicines Consortium (SMC) will decide whether ocrelizumab should be available on the NHS in Scotland.
We hope these decisions will be made by the end of 2018.
Genevieve Edwards, our Director of External Affairs, said: “This is a significant day for people with primary progressive MS, who have never had an effective treatment. We know, however, that limitations on who can use ocrelizumab will be disappointing to some people with progressive forms of the condition, who still don’t have treatment options.
“This is an important step towards effective medicine for everyone with MS, but the next challenge is making ocrelizumab available on the NHS. We urge the manufacturer and appraisal bodies across the UK to make that happen as soon as possible, recognising the critical unmet need for treatment for thousands living with the condition.”