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DIR Return to: OCREVUS (ocrelizumab)
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#Post#: 1503--------------------------------------------------
FDA approval of Ocrevus (ocrelizumab) delayed
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
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.[/quote]
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