At last the clock starts ticking for the long ocrelizumab wait #NewsSpeak #Ocrelizumab #MSBlog
"You may have heard already that Roche have finally submitted their RRMS and PPMS dossiers in relation to ocrelizumab to the FDA and EMA (see today's press release below). Ocrelizumab illustrates how long the drug development process takes. The PPMS ocrelizumab results were made public last year at ECTRIMS and the dossier has only just been submitted approximately 9 months later. The FDA has fast-tracked ocrelizumab so PPMSers in the US should get an answer within 6 months. In Europe the EMA will take up to 12 months and then NICE will have to look at its cos-effectiveness, which typically takes 6-12 months and then post-NICE there is a 3 month delay before NHS England allows us to use it. So in the UK anyone with PPMS hoping to be started on ocrelizumab may have to wait another 2 years, that is assuming is clears all the regulatory and access hurdles. The red tape is unbelievable and then you ask us why academics don't develop drugs?"
Labels: EMA, FDA, NewsSpeak, ocrelizumab, Primary Progressive MS, Roche