Ocrevus: FDA Approves First Drug to Treat Two Forms of MS

[johnMSAA]

Here is an excerpt from MSAA's article on the latest MS treatment news:

"On March 28, 2017, the United States Food and Drug Administration (FDA) announced the approval of Ocrevus™ (ocrelizumab) for the treatment of two types of multiple sclerosis (MS): relapsing forms of MS (RMS) and primary-progressive MS (PPMS). This is the first time that a medication has been approved for two types of MS, and the first time that any medication has been approved for PPMS.

As noted, the approval is for relapsing forms of MS (RMS), which are characterized by sudden flare-ups and remissions. RMS includes relapsing-remitting MS (RRMS) as well as secondary-progressive MS (SPMS) with relapses. The approval is also for primary-progressive MS (PPMS), which is a less-common form of the disease and is characterized by a steady accumulation of symptoms.

Ocrevus™ (ocrelizumab) is a humanized monoclonal antibody and is given via intravenous (IV) infusion every six months. It has been shown to reduce annualized relapse rates and reduce disability progression when compared to control groups taking either an approved disease-modifying therapy or a placebo."

For more on Ocrevus, you can read MSAA's full news article here:

mymsaa.org/news/fda-approve...

Thank you,

- John, MSAA

[CalfeeChick CommunityAmbassador]

Thank you John, this is so exciting. Have been waiting for this news. I am praying that after this second round of testing, I am given a definitive diagnosis, and maybe get to start on this medication or another. I want to get some normalcy back in my life. 👍😊💐

[johnMSAA Partner in reply to CalfeeChick]

Glad you appreciated the news, CalfeeChick , as I'm sure many members on here and across the country in the MS community did!

- John, MSAA

[Iona60]

Thanks for posting this John. I read it earlier and was glad to see that the tumor issue was addressed. We've been talking about that here recently.

[johnMSAA Partner in reply to Iona60]

No problem, Iona60 ! We are here to provide as accurate as can be info. As of today, what is in our article is all we know from the makers of the medication so far. In the next two weeks, they say there will be more info for patients and medical professionals.

- John, MSAA

[Shelly36]

I read about this yesterday, I get your daily emails, and I am so excited to talk with my doctor about possibly changing my med. They finally found a drug that can help us! I'm looking forward to seeing anything else they can find.

[johnMSAA Partner in reply to Shelly36]

Glad we can help give you the best info on the ever-changing world of MS, Shelly36 ! Best of luck in your health discussions with your doc.

- John, MSAA

[Shelly36 in reply to johnMSAA]

I just got home from my doc appt, she recommends the Ocrevus for me! I filled out the paperwork for it and now it's a waiting game to see if my insurance will cover it. I asked about the cancer risk and she doesn't think it'll be an issue because it doesn't run in my family. I have been taking Tysabri for a year now, no issues with Pml or serious infections. I had to do blood work at the office for Hepatitis possibilities. I'm so excited to start this med. I've read nothing but good about it minus the cancer scares. Wish me luck and I'll keep you all updated 😀

[johnMSAA Partner in reply to Shelly36]

Best of luck with any possible new treatment, Shelly36 !

- John, MSAA

[JennS77 in reply to Shelly36]

How long did your approval for Ocrevus take? This waiting game is a killer.

[BillD999]

Thanks for the info. Here is another article about Ocrevus -

tischms.org/news/ocrelizuma...

[Shelly36]

Well I'm playing the waiting game again! My insurance doesn't cover it all and I have to come up with $3550 for my 2nd infusion. I called Ocrevous for help and they referred my case to another source. Now I just need to wait for them to call me back. Grrrr!

[johnMSAA Partner]

Thanks for the update, Shelly36 . Sorry for what you're going through with insurance, which I'm sure many members here have encountered as well.

I know you said you called Ocrevus for help, but did you use the patient-assistance program that its manufacturer Genentech has as welll? Access Solutions:

(866) 4ACCESS [or [phone]] or Genentech-Access.com

You can also speak with a trained Client Services Specialist here at MSAA who may have some additional resources via our Helpline at [phone], extension 154; via email at [e-mail], or via online chat (during select business hours) at mymsaa.org/chat

- John, MSAA

[Shelly36]

This info is extremely helpful! I'm kicking myself in the ass because I switched my insurance to Humana and I'm finding not a lot of doctors take this insurance. I was trying to help myself with the costs of medicine and MRI, it backfired big time! Thank you so much for the information John!

[johnMSAA Partner in reply to Shelly36]

Any time, glad it could help...that's what we're here for!

- John, MSAA

[Janis_b]

Hi John! Do you know how long it takes to notice even the smallest improvement after an Ocrevus infusion??

Also, what do you know about side effects? I have had a very bad case of PPMS for 8 years now. Have tried a bostload of different DMT's without success. Ocrevus was the first med that I had a reaction to. I had severe fatigue for about 10 days after the first infusion. My neurologist stopped the treatment. I haven't heard of anyone else getting extreme fatigue. What do you think? Would be grateful to hear from you. Thanks very much!

[amc8184 in reply to Janis_b]

Hi Janis_b

Thank you for reaching out with these questions, they are great ones and definitely some to flag for the community and your doctor as well. In regards to your question on noticing Ocrevus medication effects this is tricky because it can vary from person to person how/if a medication is effective and when it might show changes. Infusion reactions are noted as the most common side effects with Ocrevus; I don't know that extreme fatigue is something patients have experienced, not to say it hasn't occurred but it is listed as a side effect to inform your doctor about if it occurs, ocrevus.com/. Because you had this type of reaction and for the amount of time it lasted, the doctor may not have felt comfortable keeping you on the treatment. Have you had a chance to talk to your doctor about these questions and effects of the Ocrevus? Hopefully they can discuss next steps moving forward with your treatment plan and what they think would be appropriate to do next. You can also try to talk to one of the Nurse Navigators on the Ocrevus patient assistance line, phone [phone]. I hope this is helpful and I wish you the best with your care moving forward. Take care.

Angel, MSAA Client Services Specialist

[Janis_b in reply to amc8184]

Thanks so much for taking the time to respond to my questions.

I have discussed the extreme fatigue I experienced with my neurologist. At this point, continuing with the Ocrevus has been put on hold, which is very disappointing.

I have also been wondering if the benadyl administered through the IV could have reacted with the other meds I currently take. The length of time the extreme fatigue lasted perplexes me. Am seeing my neurologist soon and will definitely ask.

Thanks again so much