– More than 50 Company- and Partner-Sponsored Presentations from the Biogen Idec MS Franchise and Pipeline to be Presented at the MS Community’s Largest Medical Meeting –
“For nearly 20 years,
Data from the Biogen Idec MS Pipeline
Key scientific highlights being presented during ECTRIMS from the company’s pipeline will include analyses of pooled data from the Phase 3 DEFINE and CONFIRM clinical trials of oral dimethyl fumarate (BG-12), primary results from the daclizumab high-yield process (DAC HYP) SELECTION study, and early-stage research showing the results of a study of anti-LINGO 1 (BIIB033) in optic nerve damage in animal models.
Dimethyl fumarate has been studied as an oral agent for MS and is currently under regulatory review in
- Clinical efficacy of BG-12 in relapsing-remitting multiple sclerosis: an integrated analysis of the Phase 3 DEFINE and CONFIRM studies – Platform 151
- Safety and tolerability of BG-12 in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the placebo-controlled studies – Poster 484
- Effects of BG-12 on magnetic resonance imaging outcomes in relapsing-remitting multiple sclerosis: an integrated analysis of the Phase 3 DEFINE and CONFIRM studies – Poster 920
- Long-term safety and tolerability of oral BG-12 (dimethyl fumarate) in relapsing-remitting multiple sclerosis: interim results from ENDORSE – Late Breaker Poster 1103
DAC HYP is an investigational, once-monthly subcutaneous therapy that is in Phase 3 clinical development for the treatment of RRMS. Five DAC HYP posters will be presented, along with one late breaking news platform presentation of the primary results from the SELECTION study, a randomized, double-blind extension study designed to assess sustained efficacy and safety of DAC HYP in the second year of treatment. Highlights include:
- The effect of daclizumab HYP on sustained disability progression in the SELECT trial – Poster 949
- Effect of daclizumab HYP treatment in highly active relapsing-remitting multiple sclerosis: results from the SELECT study – Poster 463
- Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis – Late Breaker Presentation 169
Anti-LINGO 1 is a monoclonal antibody in early stage clinical trials. Previous data from animal models have shown that it promotes remyelination and axon survival. Proof of concept studies in optic neuritis are expected to start in the fourth quarter of this year, and during the second half of 2013 for MS. Two company-sponsored anti-LINGO 1 posters will be presented at the
- BIIB033 Anti-LINGO-1 antibody reduces optic nerve axonal degeneration in MOG- EAE rodent models – Poster 785
- Technical feasibility of implementing multifocal VEP for multicentre clinical trials – Poster 281
Data from the Biogen Idec MS Franchise
TYSABRI is approved in
- Long-term safety and efficacy of natalizumab and assessment of 2-year freedom from clinical disease activity in patients with multiple sclerosis in the TYSABRI Observational Program (TOP) – Poster 519
- Improvement of MS-related fatigue also significantly improves quality of life in patients treated with natalizumab: results from the TYNERGY trial – Poster 445
- Relation of disease activity-free status to visual function in the AFFIRM trial – Poster 557
- Utilization of JC-virus antibody testing in clinical practice – Poster 546
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX PEN, the first intramuscular autoinjector approved for MS, is available in the
- Interim analysis of AMETYST: a Phase 4 observational study of the impact of intramuscular interferon beta-1a on quality of life, disability, and cognition in patients with clinically isolated syndrome/clinically definite multiple sclerosis – Poster 1047
- Interferon beta‐1a (AVONEX) as treatment option for untreated MS patients (AXIOM) – Poster 1007
FAMPYRA is a novel MS treatment approved in the
Dalfampridine extended release tablets: safety profile after 2 years
of post-marketing experience in
the United States– Poster 1026, sponsored by Acorda Therapeutics
- An alternative approach to estimate the health economic value of a non-disease modifying therapy for patients with multiple sclerosis: a Swedish application – Poster 1032
Through cutting-edge science and medicine,
About Dimethyl Fumarate
Dimethyl fumarate, also known as BG-12, is an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS. Dimethyl fumarate is the only currently known investigational compound for the treatment of RRMS that has experimentally demonstrated activation of the Nrf-2 pathway.
Dimethyl fumarate is currently under review by regulatory authorities in
About DAC HYP
Daclizumab high-yield process (DAC HYP) is a subcutaneous formulation of daclizumab in late-stage clinical development for the treatment of RRMS, the most common form of MS.
DAC HYP is currently being studied in the DECIDE Phase 3 clinical trial, which is evaluating the efficacy and safety of once-monthly subcutaneous DAC HYP as a monotherapy compared to interferon beta 1-a therapy.
TYSABRI is approved in more than 65 countries. TYSABRI is approved in
TYSABRI has advanced the treatment of MS patients with its established
efficacy. Data from the Phase 3 AFFIRM trial, which was published in
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain, which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved.
TYSABRI is marketed and distributed by
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with MS in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with MS.
Two AVONEX dosing innovations were recently approved by regulators in
Symptoms of depression, suicidal ideation, or psychosis, and cases of suicide, have been reported with increased frequency with patients receiving AVONEX. Severe hepatic injury, including cases of hepatic failure has been reported rarely in patients. Rare cases of anaphylaxis have been reported. While beta interferons do not have any known direct cardiac toxicity, cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition. Decreased peripheral blood counts have been reported from postmarketing experience. Seizures have been reported in patients using AVONEX, including patients with no prior history of seizure. Autoimmune disorders of multiple target organs have been reported. Routine periodic blood chemistry, hematology, liver function, and thyroid function tests are recommended. There are no adequate and well-controlled studies in pregnant women. AVONEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The most common side effects associated with AVONEX treatment are flu-like symptoms, including chills, fever, myalgia, and asthenia.
For additional important safety information, and the complete
FAMPYRA is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine). FAMPYRA has been developed to improve walking in adult patients with MS. In MS, damaged myelin exposes channels in the membrane of axons allowing potassium ions to leak, weakening the electrical current sent through nerves. Studies have shown that fampridine can increase conduction along damaged nerves, which may result in improved walking ability. This prolonged-release formulation was developed and is being commercialized in
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