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(DIR) Return to: COPAXONE (glatiramer acetate)
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#Post#: 2432--------------------------------------------------
Long-acting glatiramer acetate (GA Depot) for RRMS and PPMS anno
unced
By: agate Date: March 9, 2019, 1:39 am
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This new MS drug, to be marketed for RRMS and PPMS, seems to be
a "depot" version of glatiramer acetate (Copaxone), injected
every 4 weeks. Just when it will become available isn't clear:
(HTM) http://www.globenewswire.com/news-release/2019/02/21/1739488/0/en/Mapi-Pharma-to-Host-Key-Opinion-Leader-Meeting-on-Long-Acting-Glatiramer-Acetate-GA-Depot-for-Primary-Progressive-Multiple-Sclerosis-and-New-Treatments-for-MS.html
#Post#: 2445--------------------------------------------------
Re: Long-acting glatiramer acetate (GA Depot) for RRMS and PPMS
announced
By: ewizabeth Date: March 25, 2019, 11:10 am
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I bet that will be expensive compared to the injections.
#Post#: 2447--------------------------------------------------
Re: Long-acting glatiramer acetate (GA Depot) for RRMS and PPMS
announced
By: agate Date: March 25, 2019, 11:26 am
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The drug companies usually seem to charge whatever price the
market will bear--and the sky may be the limit.
#Post#: 3019--------------------------------------------------
Mapi Pharma presents GA Depot results at ACTRIMS/ECTRIMS 2020 me
eting
By: agate Date: September 11, 2020, 12:05 am
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I avoid drug-company publications that seem to be largely just
promoting a particular drug but this one caught my eye because
what is being considered is using GA Depot for PPMS.
This is from an e-mail I received today from MAPI Pharma Ltd.:
Mapi Pharma Presents Glatiramer Acetate Depot (GA Depot) Results
at the 8th Joint ACTRIMS-ECTRIMS Meeting MSVirtual2020
Data suggest that GA Depot may also have potential as a primary
progressive multiple sclerosis (PPMS) treatment
NESS ZIONA, Israel – Sep. 10th, 2020 – Mapi Pharma Ltd., a fully
integrated, late-stage clinical development biopharmaceutical
company, today announced that it will present data from its
ongoing Phase II studies of GA Depot for the treatment of
relapsing remitting multiple sclerosis (RRMS) and primary
progressive multiple sclerosis (PPMS) at MS Virtual 2020, the
8th Joint Meeting of the Americas Committee for Treatment and
Research in Multiple Sclerosis and the European Committee for
Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS),
which will take place virtually on September 11-13.
In the RRMS extension phase II study, all participants received
a 40mg dose of GA Depot once every four weeks for the 52-week
core study period. Adverse events (AEs) mainly included mild
injection site reactions, and no unexpected AEs were reported.
Subjects who completed 13 injections were able to enter the
optional extension study. The number of AEs was significantly
reduced during the extension study compared to the core study,
particularly during the fourth extension year as compared to the
first two years of the study. No systemic immediate
post-injection reactions were detected. Mean Expanded Disability
Status Scale (EDSS) score after four years showed no change
compared to baseline. No selapses or MRI activity were noted
during that period. Four years of Three Parameter No Evidence of
Disease Activity (NEDA-3) was achieved by 90% of the per
protocol population, which is defined as no relapses, no
increase in disability (as measured by EDSS), and no new or
active (enhancing) lesions on their MRI scans.
In the PPMS Phase II study, all participants received a 40mg
dose of GA Depot once every four weeks. AEs were mainly mild.
The most common AEs included injection site reactions and
general weakness. No unexpected AEs were reported. EDSS score
remained stable for all patients and no 12-week Confirmed
Disability Progression (CDP) was detected. Mean Nine Hole Peg
Test (9HPT) scores and Timed 25-Foot Walk (T25FW) remained
stable.
Ehud Marom, Chairman and Chief Executive Officer of Mapi, said,
“We are encouraged by the high four-year NEDA-3 score which we
believe will position GA Depot among the leading MS treatments.
The study provided evidence of the product’s long-term safety,
tolerability, and efficacy in RRMS patients and offered very
strong rationale for continued development.
“We are also pleased to report that we have now dosed more than
300 patients in our ongoing Phase 3 study for RRMS, which is
designed to support a New Drug Application (NDA).
Notwithstanding the impact that the COVID-19 pandemic has had on
drug development timelines around the world, we remain on track
to complete this study as planned with no change to our original
plan. Importantly, GA-based therapies are deemed safe by the
Multiple Sclerosis International Federation (MSIF) to be dosed
in a COVID-19 environment. We are very much looking forward to
data from this Phase 3 study and continue to work closely with
our commercialization partner Mylan to bring this significant
therapeutic advancement to MS patients globally.”
Rajiv Malik, President of Mylan, commented, “Mylan is committed
to meeting unmet needs through our collaboration with Mapi by
leveraging our global platform and scientific and commercial
expertise to advance new treatment options for patients living
with MS. The results of Mapi’s RRMS Phase 2 study and continued
progress on the recruitment for the ongoing Phase 3 study
represent additional positive steps forward in our efforts to
serve the MS patient community, which already includes the
offering of a comprehensive MS portfolio of medicines such as
glatiramer acetate 20 mg/mL and 40 mg/mL, and more recently
dimethyl fumarate delayed release capsules. In parallel to the
efficient, ongoing clinical development, we continue to advance
commercial planning to bring GA Depot to market and look forward
to expanding access for patients.”
...
Abstract Number: #2107, Poster Number: LB1228
Abstract Title: Glatiramer Acetate Depot (Extended-Release)
Phase IIa Study in Patients with RRMS: Safety, Tolerability and
Efficacy Four-Years Analysis
Abstract Number: #2106, Poster Number: LB1227
Abstract Title: Glatiramer Acetate Depot (extended-release)
Phase IIa study in patients with Primary Progressive Multiple
Sclerosis: safety and efficacy snapshot
About GA Depot:
GA Depot is a long acting injection version of the approved
Glatiramer Acetate (GA, commercially available as Copaxone®),
designed to be administered as an intramuscular injection once
every four weeks. GA Depot is intended to be used for treatment
of relapsing forms of multiple sclerosis (RMS), and is currently
evaluated in a multinational Phase III clinical study. GA Depot
is also currently being tested in Phase II for primary
progressive multiple sclerosis (PPMS). [italics added]
About Mapi Pharma:
Mapi is a clinical stage pharmaceutical company, engaged in the
development of high barrier-to-entry and high added-value life
cycle management (“LCM”) products that target large markets and
generic drugs that include complex active pharmaceutical
ingredients (“APIs”) and formulations. The GA Depot injection,
administered once every four weeks, is the first in a series of
depot long-acting injections in the company’s pipeline, for the
treatment of MS. The product is a LCM version of Copaxone®,
which requires injections daily or every other day. Mapi Pharma
partnered with Mylan N.V. (NASDAQ: MYL) for GA Depot in an
agreement under which Mylan was granted an exclusive license to
commercialize the GA Depot injection product for relapsing forms
of multiple sclerosis. Mapi is built on strong chemical and
pharmaceutical R&D capabilities, a deep understanding of the
global market and of regulatory needs. Mapi is headquartered in
Israel, with R&D facilities in Israel and China, an API
production facility in the Neot-Hovav Eco Industrial Park and an
aseptic manufacturing and a Fill & Finish facility for
injectable Finished Dosage Forms in Jerusalem. Mapi has a strong
IP position, filing numerous patent applications for APIs and
formulations. Mapi Pharma was founded by Ehud Marom who serves
as Chairman & CEO of Mapi Pharma and Stem Cell Medicine. For
more information, please visit: www.mapi-pharma.com
(HTM) http://www.mapi-pharma.com/
#Post#: 3693--------------------------------------------------
Use of GA depot for progressive MS given US patent
By: agate Date: June 24, 2022, 1:11 am
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The injection, given every 4 weeks, is intramuscular. The main
justification for bringing this new type of glatiramer acetate
onto the market seems to be that it would be more convenient for
people, and so patient compliance would be improved.
From Multiple Sclerosis News Today (April 2, 2022)--"Use of GA
Depot in Treating Progressive MS Given US Patent":
(HTM) https://multiplesclerosisnewstoday.com/news-posts/2022/04/1/ga-depot-mapi-pharma-given-us-patent-treatment-progressive-ms/
#Post#: 4013--------------------------------------------------
(AAN) Results of Phase 3 study of GA Depot, with IM injections e
very 4 weeks
By: agate Date: May 1, 2023, 6:37 pm
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Presented at the recent annual AAN meeting (April 23-27),
"Results of a Phase 3, Multinational, Double-blind,
Placebo-controlled Study in Subjects with Relapsing Forms of
Multiple Sclerosis (RMS) to Assess the Efficacy, Safety, and
Tolerability of GA Depot, a Long-Acting IM Injection of
Glatiramer Acetate, Administered Once Every 4 Weeks":
(HTM) https://bit.ly/3LKy2GJ
It isn't clear whether these IM injections were administered by
the patients at home. I'm assuming that the patients didn't have
to travel somewhere to have a medical professional do the
injection every 4 weeks.
Also, nothing is said about the immediate post-injection
reaction (IPIR) that some people have had while taking this
drug. Would they still occur with this new method of injecting
glatiramer?
#Post#: 4339--------------------------------------------------
(ACTRIMS) Glatiramer acetate depot safety profile as potential M
S therapy
By: agate Date: March 6, 2024, 1:52 am
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I avoid reports on open-label studies and reports that seem to
come from pharmaceutical companies but this one is an exception,
mainly because I am personally interested in this new version of
glatiramer acetate, which might be available before long.
From the recent ACTRIMS conference, this report appears in
NeurologyLive (March 1, 2024)--"Glatiramer Acetate Depot
Demonstrates Sustained Longterm Safety Profile as Potential MS
Therapy":
(HTM) https://bit.ly/3P5qcso
This statement is puzzling:
[quote]
[font=segoe ui]In the study, the most frequently reported
treatment-emergent adverse events (TEAEs) included injection
site reactions (ISRs), pyrexia, influenza-like illness, body
temperature increase, and headache; however, these TEAEs were
considered mostly mild or moderate (98.3% of events).[/font]
[/quote]
[font=segoe ui]"Treatment-emergent adverse events" apparently
means side effects experienced by patients while taking GA
Depot.[/font]
[font=segoe ui]As someone who took Copaxone for nearly 3 years
(daily injection) and now is taking Glatopa (3 times a week
injection), I'm surprised by the list of side effects
experienced with GA Depot--"influenza-like illness" and "body
temperature increase" are not typical side effects of Copaxone
or Glatopa.[/font]
[font=segoe ui]However, they are side effects often experienced
while taking Avonex.[/font]
[font=segoe ui]I'm guessing that the intramuscular injection
that is used with GA Depot might account for the different
TEAEs.[/font]
#Post#: 4346--------------------------------------------------
US FDA declines to approve GA Depot (yet)
By: agate Date: March 12, 2024, 1:58 pm
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The US FDA has declined to approve GA Depot. Apparently more
information is needed, and this may be just a matter of a delay.
From Neurology Live (March 22, 2024)--"FDA Issues Complete
Response Letter for Long-Acting Form of Glatiramer Acetate for
Relapsing Multiple Sclerosis":
(HTM) https://bit.ly/48QUXIA
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