Author Topic: Coming soon: Ocrevus (ocrelizumab), now FDA-approved  (Read 118 times)

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Offline agate

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Coming soon: Ocrevus (ocrelizumab), now FDA-approved
« on: March 29, 2017, 08:50:11 am »
On March 28 the US FDA approved Ocrevus (ocrelizumab), being hailed as the first drug to treat PPMS.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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From the NEJM Journal Watch, March 30, 2017:

Quote
FDA Approves Ocrelizumab for Severe MS

By Kelly Young

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

The FDA has approved the injectable monoclonal antibody ocrelizumab (Ocrevus) to treat primary progressive multiple sclerosis (PPMS) and relapsing MS in adults. The treatment depletes B cells via binding by CD20.

In two recent trials of nearly 1700 patients with relapsing MS, patients randomized to ocrelizumab had a 47% reduction in relapse rate, a 40% reduction in worsening disability, and over a 95% reduction in new lesions after 3 months compared with those given high-dose interferon.

In a recent PPMS trial, 33% of patients given ocrelizumab had worsening disability at 3 months, versus 39% in the placebo group.

Ocrelizumab is associated with infusion-related reactions, which can include laryngeal or pharyngeal edema, hypotension, and tachycardia. The treatment may increase risk for cancers, specifically breast cancer, but the most common side effects were respiratory tract and skin infections. In addition, patients with active infections should delay treatment, given a higher rate of infections seen with ocrelizumab in clinical trials. Lastly, vaccination with live or live attenuated vaccines is not advised during treatment.

The drug's list price will be $65,000 a year, the New York Times reports.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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Panel of experts: Is Ocrevus worth the cost?
« Reply #2 on: April 01, 2017, 05:20:21 pm »
Some MS experts were interviewed about the cost of Ocrevus. From MedPage Today, March 31, 2017:

https://www.medpagetoday.com/Neurology/MultipleSclerosis/64261?xid=nl_mpt_DHE_2017-04-01&eun=g345846d0r&pos=0
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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NMSS on Ocrevus
« Reply #3 on: April 05, 2017, 11:15:40 am »
From the National MS Society:

http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Ocrevus

One question I've had is whether Ocrevus will be prescribed for people with SPMS. Maybe, maybe not, according to the NMSS Website (see link above):

Quote
Q. Will Ocrevus help people with secondary progressive MS who are no longer experiencing relapses?

A. We donít know. So far, the clinical trials of Ocrevus have involved people with relapsing forms of MS and primary progressive MS. Results were announced as positive for the trials in these populations. There is no data yet on whether Ocrevus may be effective in those people with secondary progressive MS who are no longer experiencing relapses.

MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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