[PRNewswire] Merck to Showcase New Data at ACTRIMS-ECTRIMS ... (2/2)
MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis
- Not intended for UK and US based media
- Company to present 54 abstracts across its MS portfolio - MAVENCLAD(R) (cladribine tablets), Rebif(R) (interferon beta-1a) and investigational evobrutinib
- New long-term data and real-world evidence further characterise efficacy and safety of MAVENCLAD(R)
- New MAVENCLAD(R) and Rebif(R) safety data to be shared demonstrating no increased risk of respiratory viral infections
(DARMSTADT, Germany, Sept. 3, 2020 PRNewswire=연합뉴스) General MS Franchise
Title: Identifying Gaps in Knowledge, Skills and Confidence Among MS Specialists to Facilitate Improved MS Care
Authors: Schmierer K, Peniuta M, Oh J, Leist T, Lazure P, Peloquin S
Presentation ID: P1100
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: Klaus Schmierer
Title: An Investigation Into the Role and Impact That Carers Play in Consultations Between Healthcare Professionals and People With MS
Authors: Langdon D, Sumelahti M L, Potra S, Alroughani R, on behalf of the MS in the 21st Century initiative, Verdun Di Cantogno E
Presentation ID: P1006
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: Dawn Langdon
Title: Characterization of Age-related Changes in Circulating T cells in Multiple Sclerosis and Normal Controls: A Pilot Study
Authors: Zuroff LR, Li R, Shinoda K, Rezk A, Bar-Or A
Presentation ID: P0952
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: LR Zuroff
Title: Treatment and Care Management, Clinical Outcomes and Mobility Impairment in People With or Without MS Aged ≥50 Years: Observational 6-year Analysis
Authors: Freeman L, Lucas A, Zhou J, Hayward B, Livingston T
Presentation ID: P0176
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: Terrie Livingston
About MAVENCLAD(R)
MAVENCLAD(R) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD(R) for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD(R) has since then been approved in 79 countries, including Canada, Australia and the US. Refer to the respective prescribing information for further details.
The clinical development programme for cladribine tablets includes:
- The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.
- The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.
- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
- The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.
In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.
About Rebif(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif(R) in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif(R) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.
Rebif(R) can be administered with the RebiSmart(R) electronic auto-injection device (not approved in the US), or with the RebiDose(R) single-use disposable pen, or the manual multidose injection pen RebiSlide™. Rebif(R) can also be administered with the autoinjector Rebiject II(R) or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.
In January 2012, the European commission approved the extension of the indication of Rebif(R) in early multiple sclerosis. The extension of the indication of Rebif(R) has not been submitted in the United States.
Rebif(R) should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif(R) with their doctors.
*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
Rebif(R) (interferon beta-1a) is approved in the United States for relapsing forms of MS.
About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.
The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus osteoarthritis and psoriasis.
All Merck Press Releases are distributed by email at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2019, Merck generated sales of € 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Contact
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694
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Merck Logo
(끝)
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MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis
- Not intended for UK and US based media
- Company to present 54 abstracts across its MS portfolio - MAVENCLAD(R) (cladribine tablets), Rebif(R) (interferon beta-1a) and investigational evobrutinib
- New long-term data and real-world evidence further characterise efficacy and safety of MAVENCLAD(R)
- New MAVENCLAD(R) and Rebif(R) safety data to be shared demonstrating no increased risk of respiratory viral infections
(DARMSTADT, Germany, Sept. 3, 2020 PRNewswire=연합뉴스) General MS Franchise
Title: Identifying Gaps in Knowledge, Skills and Confidence Among MS Specialists to Facilitate Improved MS Care
Authors: Schmierer K, Peniuta M, Oh J, Leist T, Lazure P, Peloquin S
Presentation ID: P1100
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: Klaus Schmierer
Title: An Investigation Into the Role and Impact That Carers Play in Consultations Between Healthcare Professionals and People With MS
Authors: Langdon D, Sumelahti M L, Potra S, Alroughani R, on behalf of the MS in the 21st Century initiative, Verdun Di Cantogno E
Presentation ID: P1006
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: Dawn Langdon
Title: Characterization of Age-related Changes in Circulating T cells in Multiple Sclerosis and Normal Controls: A Pilot Study
Authors: Zuroff LR, Li R, Shinoda K, Rezk A, Bar-Or A
Presentation ID: P0952
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: LR Zuroff
Title: Treatment and Care Management, Clinical Outcomes and Mobility Impairment in People With or Without MS Aged ≥50 Years: Observational 6-year Analysis
Authors: Freeman L, Lucas A, Zhou J, Hayward B, Livingston T
Presentation ID: P0176
Presentation Details:
- Session: ePoster
- Date: 11-13 September 2020
- Time: Available from 9am EDT on 11 September 2020
- Presenter: Terrie Livingston
About MAVENCLAD(R)
MAVENCLAD(R) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD(R) for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD(R) has since then been approved in 79 countries, including Canada, Australia and the US. Refer to the respective prescribing information for further details.
The clinical development programme for cladribine tablets includes:
- The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.
- The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.
- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
- The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.
In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.
About Rebif(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif(R) in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif(R) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.
Rebif(R) can be administered with the RebiSmart(R) electronic auto-injection device (not approved in the US), or with the RebiDose(R) single-use disposable pen, or the manual multidose injection pen RebiSlide™. Rebif(R) can also be administered with the autoinjector Rebiject II(R) or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.
In January 2012, the European commission approved the extension of the indication of Rebif(R) in early multiple sclerosis. The extension of the indication of Rebif(R) has not been submitted in the United States.
Rebif(R) should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif(R) with their doctors.
*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
Rebif(R) (interferon beta-1a) is approved in the United States for relapsing forms of MS.
About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.
The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus osteoarthritis and psoriasis.
All Merck Press Releases are distributed by email at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2019, Merck generated sales of € 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Contact
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694
Logo - https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg
Merck Logo
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