EMA approval process

Primary progressive MS
1

Hi everybody,

regarding Ocrevus which we know is the marketing name for Ocrelizumab. The FDA have granted it breakthrough status and so it will be fast-tracked. Assuming they approve this drug will the EMA (Europoean authority) also grant approval automatically or will they then have to repeat the whole process, does anybody out there know?

Dave.

2

Sorry Dave I have no idea, but am sure someone here will have the answer.

Pam x

3

I heard they were fast-tracking it in the US too but not read anything concrete on the UK front yet

Sonia x