Author Topic: Long-acting glatiramer acetate (GA Depot) for RRMS and PPMS announced  (Read 248 times)

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Offline agate

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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:


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
« Last Edit: March 09, 2019, 09:15:49 am by agate »
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline ewizabeth

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I bet that will be expensive compared to the injections.

Offline agate

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The drug companies usually seem to charge whatever price the market will bear--and the sky may be the limit.
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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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
« Last Edit: December 10, 2020, 05:59:21 am by agate »
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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Use of GA depot for progressive MS given US patent
« Reply #4 on: June 23, 2022, 09:11:19 pm »

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":


https://multiplesclerosisnewstoday.com/news-posts/2022/04/1/ga-depot-mapi-pharma-given-us-patent-treatment-progressive-ms/
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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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":


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?
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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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":


https://bit.ly/3P5qcso


This statement is puzzling:


Quote
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).

"Treatment-emergent adverse events" apparently means side effects experienced by patients while taking GA Depot.

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.

However, they are side effects often experienced while taking Avonex.

I'm guessing that the intramuscular injection that is used with GA Depot might account for the different TEAEs.
« Last Edit: March 05, 2024, 09:54:42 pm by agate »
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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US FDA declines to approve GA Depot (yet)
« Reply #7 on: March 12, 2024, 09:58:17 am »
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":


https://bit.ly/48QUXIA



MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

 

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