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#Post#: 1614--------------------------------------------------
Coming soon: Ocrevus (ocrelizumab), now FDA-approved
By: agate Date: March 29, 2017, 12:50 pm
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On March 28 the US FDA approved Ocrevus (ocrelizumab), being
hailed as the first drug to treat PPMS.
HTML https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm
HTML https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm
#Post#: 1616--------------------------------------------------
Re: Coming soon: Ocrevus (ocrelizumab), now FDA-approved
By: agate Date: March 30, 2017, 8:51 pm
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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.[/quote]
#Post#: 1618--------------------------------------------------
Panel of experts: Is Ocrevus worth the cost?
By: agate Date: April 1, 2017, 9:20 pm
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Some MS experts were interviewed about the cost of Ocrevus. From
MedPage Today, March 31, 2017:
HTML https://www.medpagetoday.com/Neurology/MultipleSclerosis/64261?xid=nl_mpt_DHE_2017-04-01&eun=g345846d0r&pos=0
HTML https://www.medpagetoday.com/Neurology/MultipleSclerosis/64261?xid=nl_mpt_DHE_2017-04-01&eun=g345846d0r&pos=0
#Post#: 1628--------------------------------------------------
NMSS on Ocrevus
By: agate Date: April 5, 2017, 3:15 pm
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From the National MS Society:
HTML http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Ocrevus
HTML 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 don’t 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.[/quote]
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