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   DIR Return to: OCREVUS (ocrelizumab)
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       #Post#: 1503--------------------------------------------------
       FDA approval of Ocrevus (ocrelizumab) delayed 
   DIR By: agate
       Date: December 28, 2016, 6:44 pm
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       According to BusinessWire (December 20), the FDA review of
       Ocrevus (ocrelizumab) has been delayed until March 2017.  The
       delay is reported to have no connection to the efficacy or
       safety of Ocrevus:
  HTML http://www.businesswire.com/news/home/20161220005734/en
  HTML http://www.businesswire.com/news/home/20161220005734/en
       #Post#: 1572--------------------------------------------------
       FDA decision on Ocrevus due on March 28
   DIR By: agate
       Date: February 23, 2017, 7:37 pm
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       According to this (Multiple Sclerosis News Today, February 23)
       the FDA decision on Ocrevus will be made on March 28:
       --- Quote ---
       > #ACTRIMS2017 – No Evidence of Progression More Likely Among
       PPMS Patients on Ocrevus
       >
       > Magdalena Kegel
       >
       > Genentech’s Ocrevus (ocrelizumab) increased the proportion of
       patients with no evidence of progression (NEP) in the recently
       concluded ORATORIO Phase 3 clinical trial in patients with
       primary progressive multiple sclerosis (PPMS).
       >
       > The evaluation of NEP — a combined measure of three disability
       assessments — was a secondary exploratory endpoint of the
       clinical trial. Researchers presented the results of their
       analysis today at ACTRIMS 2017 Forum, taking place Feb. 23-25 in
       Orlando, Florida.
       >
       > The presentation, “Evaluation of no evidence of progression
       (NEP) in patients with primary progressive multiple sclerosis in
       the ORATORIO trial,” was part of the Poster Session 1 and
       Opening Networking Event on the meeting’s first day.
       >
       > In the ORATORIO trial (NCT01194570), a total of 230 placebo
       and 461 Ocrevus-treated PPMS patients were evaluated every 12
       weeks for up to 120 weeks. Participants received Ocrevus 600 mg
       or placebo every 24 weeks. During the study period, non-placebo
       patients received at least five 600 mg Ocrevus doses.
       >
       > NEP was defined as having no disability progression as
       measured by the Expanded Disability Status Scale (EDSS) at 12
       weeks, and no confirmed progression of 20 percent or more on the
       timed 25-foot walk test and on the 9-hole peg test. These tests
       cover the patient’s overall disability, including both arm
       function and ambulation. Patients continued evaluations until
       the end of the study or until researchers recorded a
       pre-specified number of progressions.
       >
       > At 120 weeks, 42.7 percent of Ocrevus-treated patients reached
       NEP, compared to only 29.1 percent among those receiving
       placebo. The difference represents a 47 percent relative
       increase in the Ocrevus group.
       >
       > Researchers also assessed the components of NEP in a pairwise
       manner. They found that more patients treated with Ocrevus did
       not experience progression on EDSS in combination with the
       25-foot walk test (44.7 percent versus 31.3 percent in the
       placebo group).
       >
       > Combining the 25-foot walk test and the 9-hole peg test also
       revealed a greater proportion in the Ocrevus group (48.4
       percent) than in the placebo group (36.1 percent). The smallest
       change was seen when researchers analyzed EDSS and the 9-hole
       peg test together; for these parameters, there was only a 15
       percent relative increase among Ocrevus-treated (61.4 percent)
       compared to those receiving placebo (53.5 percent).
       >
       > The U.S. Food and Drug Administration (FDA) is currently
       reviewing the Biologics License Approval for Ocrevus in the
       United States and will likely make its verdict public March 28.
       --- End Quote ---
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