FDA approves its first drug for PPMS patients

Discuss Ocrelizumab, a monoclonal antibody treatment for MS.

FDA approves its first drug for PPMS patients

Postby MSUK » Fri Mar 31, 2017 3:44 am

The US Food and Drug Administration (FDA) has approved Ocrevus, otherwise known as ocrelizumab, to treat adult patients with relapsing and primary progressive MS (PPMS)...Read more - http://www.ms-uk.org/fda-approves-its-first-drug-ppms-patients-310317
MS-UK - http://www.ms-uk.org/
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Re: FDA approves its first drug for PPMS patients

Postby HUD45 » Tue Apr 04, 2017 7:32 am

I am really curious to hear any testimonials of PPMS or SPMS patients getting treated with ocrevus.. From what I read, it is most effective on younger patients and also with active lesions on mri. I like the fact that it targets only the CD20 positive B cells, thus leaving the rest of the immune system intact.

I know of one pt. getting the infusions and it is incredibly expensive, like most all the immunologic drugs. Her infusion produced rigor shaking, took 9 hrs. No other side effects in days or weeks later.

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Re: FDA approves its first drug for PPMS patients

Postby MSKarateka » Mon Apr 10, 2017 2:10 pm

I will let you know.
I had my appointment with my doc last week and while they recommended Tsyabri, I was nervous about the side effects. I asked about Ocrevus and they agreed. She is even trying to get me into the trial which should help with the costs. I have never been treated for MS before which is a pre-requisite of the trial. I am not sure yet when this all starts.
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Re: FDA approves its first drug for PPMS patients

Postby David1949 » Mon May 15, 2017 10:16 am

I was curious so I looked up some info about Ocrevus.

Here is what I found:

Cautions
"Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus. Ocrevus must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Ocrevus can cause infusion-related reactions, which can be serious. These reactions include, but are not limited to, itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, tiredness, dizziness, headache, throat irritation, shortness of breath, swelling of the throat, nausea, and fast heartbeat. Additionally, Ocrevus may increase the risk for malignancies, particularly breast cancer. Delay Ocrevus treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving Ocrevus.
In addition to the infusion-related reactions, the most common side effect of Ocrevus seen in the clinical trials for relapsing forms of MS was upper respiratory tract infection. The most common side effects in the study of PPMS were upper respiratory tract infection, skin infection, and lower respiratory tract infection."
Source https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm

Effectiveness
"In the clinical trial data released last fall, which covered 732 people with primary progressive MS, people who took the drug had a 24 percent reduction in the progression of disability after 12 weeks compared to those who received a placebo. Study participants on the experimental medicine also experienced slower declines in walking ability and brain volume than people in the control group."
Source https://www.statnews.com/2016/02/19/progressive-multiple-sclerosis-ocrelizumab/

Cost
"Genentech, which is owned by Switzerland-based Roche, reportedly said it will charge a list price of $65,000 a year."
Source http://www.cbsnews.com/news/multiple-sclerosis-drug-ocrevus-ocrelizumab-fda-approved/

I wanted to know what it would cost me with my part D prescription drug plan so I called the insurance company and asked. The nice lady who answered the phone said ok let me look that up for you. When she came back a minute later she said: "Whew!! that drug is not covered and it would cost you $48,000 per year."

So I said thanks but no thanks.
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