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(DIR) Return to: GLATOPA (generic Copaxone - 20 mg, 40 mg)
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#Post#: 3603--------------------------------------------------
(AAN) GA Depot (extended release) Phase IIa study in patients w/
PPMS...
By: agate Date: April 5, 2022, 1:00 am
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Work is being done on a new version of glatiramer acetate (=
Copaxone). This would be an intramuscular injection every 28
days and is apparently being called GA Depot.
Presented at the annual AAN conference Monday, April 4, 2022, by
Mapi Pharma Ltd., makers of GA Depot--"Glatiramer acetate depot
(extended release) Phase IIa study in patients with primary
progressive multiple sclerosis: Safety and efficacy snapshot":
(HTM) https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-001329.html
#Post#: 3782--------------------------------------------------
Mapi Pharma announces GA Depot has done well in Phase III trial
By: agate Date: September 23, 2022, 1:23 am
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From an e-mail from Mapi Pharma (September 21, 2022). Glatiramer
acetate in an extended-release form, taken in a 40mg dose every
28 days via an intramuscular injection, may be available at some
point. It has apparently done well in Phase III trials.
[quote]
Mapi Pharma Announces Positive Top-Line Results from GA Depot
Phase III Trial for Relapsing forms of Multiple Sclerosis (RMS)
The study evaluating a long-acting glatiramer acetate injection,
GA Depot 40 mg once every four weeks, met the primary endpoint,
significantly reducing the annualized relapse rate (ARR) by 30.1
percent compared to placebo
NESS ZIONA, Israel – Sep. 21, 2022 – Mapi Pharma Ltd., a fully
integrated, late-stage clinical development pharmaceutical
company focused on introducing innovative long-acting depot
injectable products, announced today positive top-line results
from the GA Depot (a long acting glatiramer acetate) Phase III
clinical trial assessing the efficacy, safety and tolerability
of a once monthly GA Depot 40 mg compared to placebo in
relapsing forms of multiple sclerosis (RMS) patients. Top-line
efficacy results showed that GA Depot 40 mg meet the primary
endpoint versus placebo in significantly reducing the ARR. The
one-year multinational, multicenter, randomized, Phase III,
double blind, parallel group, placebo-controlled study in
subjects with relapsing forms of multiple sclerosis (RMS) to
assess the efficacy, safety and tolerability of GA Depot, IM
injection once monthly recruited 1,016 patients at 112
multinational sites.
Top Line Results Highlights
The study met its primary endpoint showing that GA Depot 40 mg
statistically significantly reduced the annualized relapse rate
(ARR) by 30.1 percent compared to placebo (p=0.0066).
Analyses of various secondary efficacy endpoints and safety are
ongoing. Following the initial 12-month placebo-controlled
period, there is an ongoing one year open-label period extension
of the trial. “We are pleased with the topline results of this
study that show the potential of GA Depot 40 mg to offer
patients an effective treatment option using a more convenient
dosing regimen which may potentially improve compliance and
adherence,” said Ehud Marom, CEO and Chairman, Mapi Pharma, “We
believe the positive results set us on a path to commercialize
GA Depot and we will work with our partner Viatris to make this
potentially valuable new treatment option available to patients
with RMS as early as possible. We look forward to providing the
other secondary endpoints and overall safety and tolerability of
the drug in the near future.”
“The positive top-line efficacy results from the GA Depot 40 mg
Phase III trial are an exciting step forward in our
long-standing commitment to supporting the needs of the multiple
sclerosis community. GA Depot has the potential to be
complementary to our comprehensive MS portfolio,” said Rajiv
Malik, President, Viatris. “We look forward to our continued
partnership with Mapi to deliver on our strategy of providing
access to more complex and novel products and our mission to
empower people worldwide to live healthier at every stage of
life.”
“In an international Phase 3 double-blind, randomized,
placebo-controlled trial, once monthly intramuscular injections
of depot glatiramer acetate (GA Depot) demonstrated
statistically significant efficacy, comparable to other
available formulations of GA, that supports its potential
designation as a first line therapy for relapsing forms of
multiple sclerosis. The monthly administration of GA Depot
should offer patients a much more preferable schedule than
current regimens of GA, a long-standing pillar in the treatment
of MS, and lead to improved patient satisfaction and medication
adherence,” said the study’s Principal Investigator Aaron
Miller, M.D., Medical Director, Corinne Goldsmith Dickinson
Center for Multiple Sclerosis, Department of Neurology, Icahn
School of Medicine at Mount Sinai, New York.
Mapi Pharma and Viatris plan to work with regulatory authorities
in the major markets to determine next steps.
About the Study
The multinational Phase III Study was designed to examine the
safety, efficacy and tolerability of glatiramer acetate (GA) 40
mg intramuscular injection administered once every four weeks
compared to placebo in a randomized double-blind
placebo-controlled design in patients with relapsing forms of
multiple sclerosis. The primary endpoint of the study is the
total number of confirmed relapses during a 12-month,
placebo-controlled phase. A total of 1,016 subjects were
randomized into two groups, receiving either 40mg of GA Depot or
placebo, via intramuscular injection (IM), once every 4 weeks
for a total of 13 doses.
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). GA Depot is also
currently being tested in Phase II for Primary Progressive
Multiple Sclerosis (PPMS).[/quote]
#Post#: 3805--------------------------------------------------
Re: Webinar 10/19 on GA Depot (IM glatiramer acetate injection e
very 4 wks.)
By: agate Date: October 12, 2022, 6:51 pm
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This upcoming Webinar may be more of a marketing occasion than
anything else but more information about the intramuscular
glatiramer injection every 4 weeks might be provided. So far it
isn't clear to me whether this intramuscular injection is meant
to be self-administered, for instance.
This is an e-mail I received from Mapi Pharma:
[quote]
Mapi Pharma to Host a Key Opinion Leader Webinar on Glatiramer
Acetate Depot
GA Depot is a Potential Long Acting Injection Solution for
Multiple Sclerosis Patients
Positive Results from Phase III GA Depot Study in Relapsing MS
to be Reviewed
Webinar on Wednesday, October 19, 2022 @ 10:30 AM ET
NESS ZIONA, Israel – October 12, 2022 – Mapi Pharma Ltd., a
fully integrated, late-stage clinical development pharmaceutical
company focused on introducing innovative long-acting depot
injectable products, announced today it will host a key opinion
leader (KOL) webinar on Glatiramer Acetate (GA) Depot, a
potential long-acting injection solution for multiple sclerosis
(MS) patients, on Wednesday, October 19, 2022 at 10:30 AM
Eastern Time.
The webinar will feature KOL neurologists Aaron Miller, MD, from
Mount Sinai, and Carlo Tornatore, MD, from Georgetown University
Medical Center, who will discuss Mapi Pharma’s successful Phase
III GA Depot clinical results and the contribution a monthly GA
Depot will potentially have on improving standard of care to MS
patients. Additionally, the KOLs will provide a comprehensive
overview on the treatment landscape for Relapsing Forms of MS
(RMS) and the unmet medical need for a long-acting monthly
injection as compared to the approved daily or 3x/week GA
injection, commercially available as Copaxone®, and its generic
versions. Ehud Marom, Mapi Pharma’s Chairman and CEO will
present the company’s promising long-acting Depot injectable
pipeline with a focus on Semaglutide (SG) Depot for treating
diabetes, weight control and potentially Parkinson’s Disease and
other Depot products which will be registered via the FDA
505(b)(2) regulatory pathway or as ANDA that address billions of
dollars markets.
A live Q&A session will follow the formal presentations. To
register for the event, please click
(HTM) https://lifesci.rampard.com/WebcastingAppv5/Events/Registration/registration.jsp?step=1&Y2lk=MjA2Nw==&sessionid=F4348FA28C227B9E8E2667734DFC01C2
Positive top-line results from the GA Depot Phase III study were
announced by Mapi Pharma in September 2022. The study is
designed to assess the efficacy, safety and tolerability of a
once-monthly GA Depot 40 mg compared to placebo in relapsing
forms of multiple sclerosis (RMS) patients. The primary
endpoint was met, showing that GA Depot 40 mg statistically
significantly reduced the annualized relapse rate (ARR) by 30.1
percent compared to placebo (p=0.0066). Mapi Pharma and its
partner Viatris plan to work with regulatory authorities in the
major markets to determine next steps.
Aaron Miller, MD, is the Medical Director of the Corinne
Dickinson Center for Multiple Sclerosis and a Professor of
Neurology at the Icahn School of Medicine at Mount Sinai. He
also serves as Vice-Chair of Education in the Department of
Neurology. For 23 years prior to becoming Medical Director, he
headed the Division of Neurology at Maimonides Medical Center in
Brooklyn, New York, where he also served as director of the
Multiple Sclerosis Care Center. Dr. Miller served as Chief
Medical Officer and Chairman of the Medical Advisory Board of
the National Multiple Sclerosis Society (NMSS) from October
2009-2022 and is the immediate past president of the National
Medical Advisory Board. He also served as the Chairman of the
Clinical Advisory Committee of New York City Chapter of the NMSS
from 1991-2004. He formerly served as the Chairman of the
Professional Education Committee of the NMSS and is a past
president of the Consortium on MS Centers. He was a member of
the National Board of the NMSS from 2022-2017. Dr. Miller
received the Hope Award from the National MS Society in 2021.
Dr. Miller was the first chairman of the multiple sclerosis
section of the American Academy for Neurology and has
participated in numerous clinical trials of new treatments for
multiple sclerosis. Dr. Miller is also very active with the
American Academy of Neurology for which he served as Editor of
Continuum Audio from 2012-2021. He was secretary of the AAN
Board (2013-2017) and also a member of the Board from 2009-2013.
From 1997-2003, he served as Co-Chairman of the Education
Committee and Chairman of the Annual Meeting Subcommittee.
CarloTornatore, MD, is Chairman and Neurologist-in-Chief of the
Department of Neurology and Executive Director of the Multiple
Sclerosis Patient-Centered Specialty Practice for Medstar at
Georgetown University Hospital. He is also Professor and
Chairman of the Department of Neurology at Georgetown University
Medical Center and Physician Executive Director for Neurology at
Medstar Health.
Dr. Tornatore earned his Master’s degree in Physiology at
Georgetown University and his medical degree at Georgetown
University Medical School. He completed his internship at
Providence Hospital and his Residency in neurology at Georgetown
University Hospital. His fellowship was completed at the
National Institute for Neurologic Disorders and Stroke at the
National Institutes of Health (NIH) in the Laboratory of
Molecular Medicine and Neuroscience in Bethesda, MD.
Dr. Tornatore is a member of the American Academy of Neurology
and American Society for Neural Transplantation. His research
interests include multiple sclerosis treatment, neuroimmunology,
neuro-AIDS, and infectious diseases of the central nervous
system, for which he has published a wide variety of articles
and book chapters. In addition, he is a reviewer for several
journals, including Annals of Neurology, Neurology and Medical
Virology.
About the Phase III Study
The multinational Phase III Study was designed to examine the
safety, efficacy and tolerability of a 40 mg GA intramuscular
injection administered once every four weeks compared to placebo
in a randomized double-blind placebo-controlled design in
patients with RMS. The primary endpoint of the study is the
total number of confirmed relapses during a 12-month,
placebo-controlled phase. A total of 1,016 subjects were
randomized into two groups, receiving either 40 mg of GA Depot
or placebo once every 4 weeks for a total of 13 doses.
About GA Depot
GA Depot is a long-acting injection version of the approved
subcutaneous GA injection, 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 RMS.[/quote]
#Post#: 4116--------------------------------------------------
FDA accepts new drug application filing for GA Depot (monthly IM
injection)
By: agate Date: August 8, 2023, 1:31 am
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From Viatris via PR Newswire (August 7, 2023)--"Viatris and Mapi
Pharma Announce FDA Acceptance of New Drug Application Filing
for GA Depot for the Treatment of Relapsing Forms of Multiple
Sclerosis":
(HTM) https://bit.ly/3Yt5K8w
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