Ocrelizumab

[J-Bo]

Marco, maybe I could have worded that a little better. I was mostly trying to reconcile opposing points of view on this to get at the answer that's mostly likely to be correct. I truly wasn't trying to impugn your knowledge on the topic. I have experienced so many cases, especially with doctors, emphatically telling me that something is so, and then finding out later that what they told me was demonstrably untrue. And not just things that you could chalk up to a different interpretation, but things that have yes/no, true/false answers. Like "No, you absolutely do not have MS. There is no question about it, irrefutably, MS is not what is causing your symptoms. Your problems are absolutely, positively NOT caused by MS.

And then, after conceding, that yes, it turns out I really do have MS <sorry> but the constant pain that I'm experiencing could not possibly be caused by MS because people with MS don't have pain as a result of it, so </sorry><sorry>we can't help you with that. Even though MS most certainly does cause pain. But try getting a satisfying conversation going on that, especially when it requires that they admit they were wrong in their original assumption.

And so on...so what I was trying to get at is that doctors tell me things all the time that don't quite hold up to scrutiny, and I just don't get how that can happen all the time, yanno? And with something like this, it almost feels like a complete fool's errand to even attempt to go that route. So what I was trying to do is see if someone had any other info from other sources that we could compare to what I'd gotten. Seems like what a lot of you said made some sense, and thank you for that.

My favorite is when some poor soul asks a question here, and people immediately admonish that person: "You should be asking your doctor, not us!" But, well, they often already did that, and if it had be helpful, they probably wouldn't have needed to come here.

But nobody did that in this thread, so it's all good.</sorry>

[Marco]

JBo,
I was just trying to explain my logic behind my statement. I'm sure that your neurologist and Mark know way more about this than I do. I just remember handing my neurologist a Christmas card that said, "All I want for Christmas is my BG-12." It was roughly 15 months later that I took my first dose of Tecfidera. I just don't want others to be disappointed if the medication isn't available in 2016 and laid out why I believe it will not be.


I completely agree with your post and the unknown is one of the most frustrating parts of MS. You can go to 5 doctors and get 5 different opinions and prognoses. It's only later that you discover that all 5 opinions were wrong. It's really a shame that even yes/no questions often get answered incorrectly. Even in my own case, dozens of doctors were wrong about one symptom and I unnecessarily suffered. Eventually, one doctor with a clue resolved the problem for me and improved my quality of life many times over. *sigh*


I still hope someone cures this blasted disease and all these forums can be CLOSED!




Have a great day!

[Marco]

I am a monkey's uncle ....

Ocrelizumab -- coming soon!

The United States Food and Drug Administration (FDA) has granted “Breakthrough Therapy Designation” for ocrelizumab, an experimental medication presently under investigation for the treatment of primary-progressive multiple sclerosis (PPMS). At this time, no treatments are available for this less-common form of MS. With this designation, the FDA affirms: (1) the medication would be used to treat a serious condition; (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies; and (3) the review process would be expedited to within 60 days.




http://mymsaa.org/news-msaa/1380-fda-expedites-review-ocrelizumab

[KoKo]

[COLOR=#141823][FONT=helvetica]Ocrelizumab -- coming soon!

The United States Food and Drug Administration (FDA) has granted “Breakthrough Therapy Designation” for ocrelizumab, an experimental medication presently under investigation for the treatment of primary-progressive multiple sclerosis (PPMS). At this time, no treatments are available for this less-common form of MS. With this designation, the FDA affirms: (1) the medication would be used to treat a serious condition; (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies; and (3) the review process would be expedited to within 60 days.

Thanks Marco! (Monkey Uncle )

I read the article you provided, and it looks very hopeful!

I just may let myself get excited now.

Take Care

[J-Bo]

This is new, right?

http://www.roche.com/investors/updat...2016-02-17.htm

Or did we already know?

[J-Bo]

Doh! I could have sworn that when I posted this, your posts weren't yet there! Anyway, good news!

[reasonable]

Ocrelizumab 2017

Hi I was told that Ocrelizumab will be available in Australia in 2017. My course of MS has not been sever. I have had MS for 20 years but its affects are primarily in hands, cognative, badder, driving etc but not the legs which are ok. I am still quite mobile and active but there is a creeping numbness especially in hands more suggestive of SPMS not RRMS. My liver did not tolerate Gilenya well and so stopped after 2 years. I am now on Tysabri for 18 months but will be swapping at this stage to Ocrelizumab after this period (I am JV+). I will be on Ocrelizumab as it is possibly affective with SPMS and PPMS. I add that I have been on Biotin for 4 months now and have definitely noticed a positive affect on Biotin. It appears that this will be the first drug, aside from Biotin which is more effective for progressive forms of MS. http://www.medpagetoday.com/MeetingC...n=g7234966d32r

[Kimba22]

Hi I was told that Ocrelizumab will be available in Australia in 2017. My course of MS has not been sever. I have had MS for 20 years but its affects are primarily in hands, cognative, badder, driving etc but not the legs which are ok. I am still quite mobile and active but there is a creeping numbness especially in hands more suggestive of SPMS not RRMS. My liver did not tolerate Gilenya well and so stopped after 2 years. I am now on Tysabri for 18 months but will be swapping at this stage to Ocrelizumab after this period (I am JV+). I will be on Ocrelizumab as it is possibly affective with SPMS and PPMS. I add that I have been on Biotin for 4 months now and have definitely noticed a positive affect on Biotin. It appears that this will be the first drug, aside from Biotin which is more effective for progressive forms of MS. http://www.medpagetoday.com/MeetingC...n=g7234966d32r

My MS Specialist expects Ocrelizumab to be approved by the FDA, "as long as they submit the data correctly." He first thought it would be approved the latter part of this year, but since Genzyme hasn't submitted any data yet, won't be until 2017 for RRMS. Ocrelizumab has received "Breakthrough status designation" for PPMS from the FDA, which will speed up the approval process if approved for PPMS. http://www.nationalmssociety.org/Abo...py-Designation Talked about safety of the drug thus far, and that progressive is still progressive and now believed to be pretty much the same thing, whether SPMS (w/o relapses) or PPMS.

Good to hear you are experiencing positive results from Biotin, and thanks for supplying us with the link.

[ireneg]

Breakthrough Therapy Designation for Ocrelizumab

I read that Ocrelizumab was given Breakthrough Therapy designation on February 17, 2016. That designation is supposed to quick track the drug through the final FDA process. 8 weeks I think. I have also heard wonderful things about Ocrelizumab. I think it is a new formulation of Rituxin which has been used to treat rheumatoid arthritis. Then I heard that Roche had not yet submitted the drug for final approval. My physician hopes there will be info at a neurological meeting in early June. Does anyone know anything else? I am anxious to have the infusions.

[Marco]

J-Bo,
I am not claiming to know more than your stellar neurologist or Marc. I was just stating my opinion and here's my rationale:

1. Unless I missed something, Roche has not submitted Ocrelizumab to the FDA
   
2. The FDA has already stated they would hasten the approval process, but it's the government in an election year
3. After approved, Roche will need to get marketing materials done, ramp up production, train infusion centers, patient assistance programs put in place
   
4. Insurance companies will need to add Ocrelizumab to formularies. Some insurance companies update monthly and others quarterly so some patients will be able to get on it sooner.
   
5. Patients will need to get into their neurologists, medication ordered, any wash-out periods completed
   
6. Whatever delays I missed ....

So even if Ocrelizumab is approved, I do not believe it will be readily available this year. I hope that I am wrong, but these approvals normally take a bit longer than any of us want.

I wish you well!

Still waiting for FDA breakthrough approval for a PPMS patients. That should still allow many PPMS patients to have their first therapy this year.

Roche is hoping RRMS approval comes Dec 28, 2016. Considering the production pipeline, patient assistance plans, etc should already be available it's conceivable that some RRMS patients get treated in Q1 2017.

[az]

Ocrelizumab Expanded-Access Program - Now Recruiting PPMS Patients!

Possibility of getting on Ocrelizumab before FDA approval. If interested, see if you qualify for this Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis. There are 52 site locations recruiting!

Here is the ClinicalTrials.gov Identifier and link:

ClinicalTrials.gov Identifier: NCT02807285

https://clinicaltrials.gov/ct2/show/...pe=Expn&rank=1

I'm considering applying but have not yet decided. Just wanted to pass on the news to those who are unaware of this program.

[J-Bo]

Thanks, az!!!

[az]

Thanks, az!!!

Wishing you best of luck, J-Bo!

[J-Bo]

Wishing you best of luck, J-Bo!

You as well, az! I looked at it, and I'm too old (60), and have had cancer, so I'm disqualified. Oh well. But I hope it helps others.

[JerryD]

So, with all that said. I nave been waiting patiently and searching for info about Ocrelizumab. If and when this drug comes to the U.S., what can I expect to gain from the Ocrelizumab infusion? Will I get the strength and balance returned to my legs and trunk ?