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ocrelizumab infusion drip

First treatment licensed for primary progressive MS in the US

Ocrelizumab has been approved as a treatment for both relapsing and primary progressive MS in the US.

It is the first licensed treatment for people with primary progressive MS. The decision was made by the US Food and Drug Administration (FDA), but we don’t have full details of the licence yet.

In its latest trial results, researchers found that ocrelizumab reduced relapses, MRI activity and slowed progression in relapsing MS. It was also found to slow progression in primary progressive MS.

What does this mean for the UK?

The US decision to license ocrelizumab is a hugely encouraging step, but in Europe we have a separate licensing process.

It’s currently being reviewed by the European Medicines Agency (EMA), the body responsible for drug licensing in Europe. We expect to hear a decision in autumn 2017.

We will have to wait for the EMA decision to know who it would be made available for in Europe.

The US decision came earlier because ocrelizumab was granted priority review status, which speeds up the licensing process.

The EMA does not have a priority review system.

If ocrelizumab is licensed in Europe, the National Institute and Care Excellence (NICE) and the Scottish Medicines Consortium will then decide whether to make it available on the NHS. We will be feeding into these reviews.

Brilliant news

Genevieve Edwards, our Director of External Affairs, said: “It’s brilliant news that ocrelizumab has been approved for both relapsing and primary progressive MS in the US. We now want to see the European Medicines Agency making the same decision – we’re due to hear in the autumn.

“More than 100,000 people are living with MS in the UK and this drug offers a lot of hope for many of them. It’s particularly exciting for people with the primary progressive form of MS who have no treatment options available to them.”

The next research breakthrough is in reach

But we need your help to get there.