Landmark decision by the CHMP; ocrelizumab gets licensed for both relapsing and primary progressive MS.
For all those pwPPMS who have been waiting for a treatment for their disease. Your wait is almost over. After many anxious months, and against the opinion of many naysayers, the CHMP (Committe for Medicinal Products for Human Use) have greenlighted ocrelizumab for the treatment of PPMS in Europe. It is not quite the liberal license of other countries, but it is a start.
"Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis
(RMS) with active disease defined by clinical or imaging features (see section 5.1).
Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple
sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features
characteristic of inflammatory activity (see section 5.1)."
The question I have for Roche is will they take up our #ThinkHand challenge and do a trial in people with more advanced MS, i.e. those who are in wheelchairs?
I personally would like to thank all the pwMS who participated in both the relapsing (Opera 1 & 2) and primary progressive (Oratorio) trials; without you we wouldn't have gotten here. Progressive MS is now a tractable problem, what we now need is combination therapy trials.
Labels: #ThinkHand, CHMP, EMA, ocrelizumab, primary progressive