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#Post#: 1111--------------------------------------------------
FDA expedites review of ocrelizumab for treating PPMS
By: agate Date: February 17, 2016, 6:57 pm
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From the MSAA, February 17, 2016:
[quote]
FDA Expedites Review of Ocrelizumab for the Treatment of PPMS
The United States Food and Drug Administration (FDA) has granted
“Breakthrough Therapy Designation” for ocrelizumab, an
experimental medication presently under investigation for the
treatment of primary-progressive multiple sclerosis (PPMS). At
this time, no treatments are available for this less-common form
of MS.
With this designation, the FDA affirms: (1) the medication would
be used to treat a serious condition; (2) preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement over existing therapies; and (3) the review process
would be expedited to within 60 days.
In contrast to relapsing-remitting MS (RRMS) – the most-common
type of multiple sclerosis affecting 80 to 85 percent of people
diagnosed with MS – about 10 percent of the MS population is
diagnosed with PPMS.
Individuals with PPMS experience a steady worsening of symptoms
from the start, without the periodic relapses and remissions
experienced by people with RRMS. While 13 disease-modifying
therapies are currently approved for relapsing forms of MS, no
long-term treatments have been approved for PPMS.
Genentech, a member of the Roche group, is the company
developing ocrelizumab. They have submitted the brand name
Ocrevus™ to the FDA for this investigational medication, noting
that this is the first drug for MS that has been designated as
breakthrough therapy by the FDA.
Ocrelizumab is an investigational, humanized monoclonal antibody
designed to selectively target CD20-positive B cells. Genentech
explains that these are a specific type of immune cell thought
to be a key contributor to myelin and axonal damage, which can
result in disability in people with MS.
According to Genentech, the breakthrough designation is based on
positive results from the pivotal Phase III ORATORIO study.
Top-line results from this study were presented at the 31st
congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) in October 2015.
These results stated that the trial met its primary endpoint,
showing that treatment with ocrelizumab in PPMS significantly
reduced the progression of clinical disability sustained for at
least 12 weeks compared with placebo. Walking speed, as measured
by the timed 25-foot walk, was improved by 29 percent. The
incidence of adverse events associated with ocrelizumab was
similar to placebo; the most common adverse events were
mild-to-moderate infusion-related reactions. MRI hyper-intense
T2 lesions were actually reduced by ocrelizumab, and
brain-volume loss as viewed on MRI was reduced by 17.5 percent.
...
Readers should note that this breakthrough designation with the
expedited review period has only been granted by the FDA for the
one indication, which is for the long-term treatment of PPMS.
Genentech also plans to seek approval of the medication for the
long-term treatment of relapsing forms of MS in the near future.
They plan to submit data from additional Phase III studies to
the FDA in the first half of 2016.
MSAA Chief Medical Officer Dr. Jack Burks states, "This is very
exciting news. Ocrelizumab is the first disease-modifying
therapy with positive disability results in PPMS. In addition,
the safety data were similar to placebo controls. However, FDA
approval will require intense scrutiny of these data.
Effectiveness combined with safety is the magic formula, and
we’ll see if the FDA agrees that ocrelizumab meets both
requirements for approval in PPMS."
For more information or to speak with a trained Client Services
Specialist, please call MSAA's Helpline at (800) 532-7667,
extension 154. Questions to MSAA's Client Services department
may also be emailed to MSquestions@mymsaa.org.
________
Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer[/quote]
#Post#: 1265--------------------------------------------------
Re: FDA expedites review of ocrelizumab for treating PPMS
By: agate Date: June 24, 2016, 1:35 pm
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From the International Progressive MS Alliance, which had its
Second Scientific Congress in May:
[quote]Federal Drug Administration designates experimental
therapy, ocrelizumab as ‘Breakthrough Therapy’ for treatment of
primary-progressive MS
Genentech, a member of the Roche Group, announced in a February
16 press release that the experimental therapy ocrelizumab has
been granted ‘Breakthrough Therapy designation’ by the U.S. Food
and Drug Administration (FDA) for the treatment of people with
primary-progressive MS. This designation means that once
Genentech files for approval of ocrelizumab to treat
primary-progressive MS, the review process can be expedited.
According to the release, Genentech plans to pursue marketing
approval for both primary-progressive MS and relapsing multiple
sclerosis, and will submit data from three phase III studies to
the FDA in the first half of 2016.
Breakthrough Therapy designation can expedite the development
and review of therapies intended to treat a serious condition
when clinical evidence indicates that the treatment may
demonstrate substantial improvement over available therapy. The
designation was granted to ocrelizumab based on phase III trial
results presented at the European Committee for Treatment and
Research in MS in late 2015. Compared to placebo, ocrelizumab
significantly reduced the risk of progression of clinical
disability by 24% in 732 people with primary-progressive MS.
Read more about these results.
“An effective treatment for people with progressive MS would be
truly life-changing,” said Dr. Alan Thompson, chair of the
International Progressive MS Alliance Scientific Steering
Committee. “We await the detailed safety and efficacy data with
great anticipation, and thanks to this expedited review process
we are very much looking forward to hearing of ocrelizumab’s
future developments and implications.”
--Read more on the ‘Breakthrough Therapy designation’ at the FDA
website, and more on ocrelizumab at the National MS Society
(NMSS) website.
- See more at:
HTML http://www.progressivemsalliance.org/announcements/federal-drug-administration-designates-experimental-therapy-ocrelizumab-as-breakthrough-therapy-for-treatment-of-primary-progressive-ms/#sthash.MI117MgB.dpuf
HTML http://www.progressivemsalliance.org/announcements/federal-drug-administration-designates-experimental-therapy-ocrelizumab-as-breakthrough-therapy-for-treatment-of-primary-progressive-ms/#sthash.MI117MgB.dpuf[/quote]
#Post#: 1266--------------------------------------------------
Re: FDA expedites review of ocrelizumab for treating PPMS
By: agate Date: June 24, 2016, 1:39 pm
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Phase 2 and 3 trials of ocrelizumab are summarized here:
[quote]Relapsing remitting MS
Two phase 3 trials (OPERA I and OPERA II) were completed in June
2015 and Roche reported positive outcomes for the effectiveness
of ocrelizumab as a treatment for relapsing remitting MS against
interferon beta-1a (also known as Rebif). The trials involved
over 1,600 people and after two years, the study is reported to
show that ocrelizumab reduced the annual relapse rate by 46% in
OPERA 1, 47% in OPERA II and the progression of clinical
disability by 40%, as measured by the Expanded Disability Status
Scale (EDSS). Additionally, the study has been reported to show
that ocrelizumab reduced the number of lesions in the brain, as
measured by MRI scans by 94%.
Roche have also reported at a conference in April 2016 that
around 50% of people taking ocrelizumab saw no evidence of
disease activity (NEDA) in both OPERA I and OPERA II, this was
compared to 25-30% of people taking interferon-beta-1a. NEDA is
defined as no relapses, no confirmed disability progression as
measured by EDSS, and no new or enlarging lesions.
Primary Progressive MS
A phase 3 trial (ORATORIO) began in 2011 to test ocrelizumab
against placebo in 732 people with primary progressive MS. This
involved two infusions 14 days apart in each treatment cycle.
Top-line results announced by Roche at a conference in April
2016 show treatment with ocrelizumab led to a reduction in the
progression of clinical disability by 25% compared to placebo.
This reduction was sustained for at least 24 weeks and was
measured by the Expanded Disability Status Scale (EDSS). Roche
also reported that ocrelizumab reduced the rate of brain atrophy
(shrinkage) by 17.5%.[/quote]
From the UK MS Society Website at
HTML https://www.mssociety.org.uk/ms-research/treatments-in-the-pipeline/ocrelizumab
HTML https://www.mssociety.org.uk/ms-research/treatments-in-the-pipeline/ocrelizumab.
#Post#: 1281--------------------------------------------------
MSAA announces availability of ocrelizumab for some PPMS patient
s soon
By: agate Date: July 6, 2016, 2:44 pm
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According to this message from the MS Association of America,
ocrelizumab should soon be available at some centers (not chosen
yet) for people diagnosed with PPMS, between the ages of 18 and
55, and with an EDSS score between 2.0 and 6.5:
HTML http://mymsaa.org/news/experimental-medication-ppms/
HTML http://mymsaa.org/news/experimental-medication-ppms/
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