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   DIR Return to: OCREVUS (ocrelizumab)
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       #Post#: 1614--------------------------------------------------
       Coming soon: Ocrevus (ocrelizumab), now FDA-approved
   DIR 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
   DIR 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.
       --- End Quote ---
       #Post#: 1618--------------------------------------------------
       Panel of experts: Is Ocrevus worth the cost?
   DIR 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
   DIR 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.
       --- End Quote ---
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