Frst PPMS medication (ocrelizumab) targeted for 2017 approval

[Marco]

A Phase 3 clinical trial, called ORATORIO, evaluating Roche's investigational ocrelizumab in patients with primary progressive multiple sclerosis (PPMS) met its primary endpoint of demonstrating reduced progression of clinical disability compared to placebo. The endpoint was defined as an increase in Expanded Disability Status Score (EDSS) that was sustained for at least 12 weeks. The incidence of serious adverse events was similar to placebo, most were infusion-related reactions. The results will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain on October 10 (Abstract #228).


Head of Global Product Development Sandra Horning, M.D., says, "People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease and there are no approved treatments for this debilitating condition. Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in [PPMS]."


Roche intends to pursue marketing authorization for ocrelizumab in both relapsing MS and PPMS. Late-stage study data will be submitted to the FDA in early 2016. About 10% of MS patients have PPMS.



Related articles:
http://uk.reuters.com/article/2015/0...0RS1M720150928

http://www.reuters.com/article/2015/...0RS0KL20150928

[Zuzus11z]

Let's see what they have to say/show in Spain. As it stands now it seems more like a huge marketing opportunity for Roche. Show me the numbers and the stats. Tell me this will be affordable if it indeed proves viable.

Tick tock.

[JerryD]

Thanks Marco. I guess I'll be seeing this information in the next issue of the MS Motivator ! I can't wait to read the article. I all the time in the world ! lol

[Kimba22]

Thank you for the information, Marco. Good to hear a treatment finally looks promising for PPMS! But if it's approved for PPMS, we all know Roche will price it at a premium.

My MS specialist has been excited about this drug (involved both in RRMS and PPMS clinical trials) for awhile. He also thought it might possibly be FDA approved by late 2016.

[hunterd]

thank you for the update Marco! It is always nice to hear good news, and rare to hear good news regarding primary progressive MS!

[pb909]

Good to hear something is getting closer.

[JerryD]

Of course, a treatment for my disease will be 'cost prohibitive'! My speculation is , probably, way off! I can only hope we will be pleasantly surprised !