New Data at AAN Showcase Biogen's Commitment to Advancing Innovation in MS
CAMBRIDGE, Mass., May 19, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced new data from its robust multiple sclerosis (MS) treatment portfolio. Additional clinical data support VUMERITY® (diroximel fumarate) as an important oral treatment option in relapsing MS and reinforce the efficacy of TECFIDERA® (dimethyl fumarate). In addition, an analysis of TYSABRI® (natalizumab) contributes to data demonstrating the reduced risk of progressive multifocal leukoencephalopathy (PML) through extended interval dosing (EID; approximately every six weeks) as compared to the currently approved dosing of every four weeks. These new data were selected for presentation at the 72nd American Academy of Neurology (AAN) annual meeting and will be available online via the 2020 AAN Science Highlights virtual platform.
“We continue to lead in MS with new data that demonstrate the strength of our portfolio and Biogen’s commitment to enhancing the care of individuals with relapsing MS,” said Bernd Kieseier, M.D., MHBA, Executive Director, Head of Global MS, Worldwide Medical, Biogen. “The data shared at AAN represent our ongoing efforts to improve the MS treatment experience and deliver therapies that provide clinically meaningful benefits to individuals living with this chronic disease.”
Data Demonstrate Early Efficacy of TECFIDERA and VUMERITY
Improved Patient-reported GI Tolerability with VUMERITY
Real-world Evidence Advances Natalizumab-associated Research
Additionally, updated analyses of real-world data from the TOUCH® Prescribing Program Database continue to demonstrate natalizumab EID is associated with a lower risk for PML than the approved Q4W dosing in anti-JC virus antibody positive patients. The most recent analysis is consistent with previous findings.
Biogen continues to evaluate the efficacy of EID in NOVA (NCT03689972), a two-year, prospective, randomized, interventional, controlled, open-label, rater-blinded, international Phase 3b study assessing the efficacy, safety and tolerability of six-week natalizumab dosing intervals in people with RRMS.
Continued Efforts to Evaluate the Treatment Experience for People Living With MS
Data Presentations Featured at AAN:
About VUMERITY® (diroximel fumarate)
VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and in patients taking dimethyl fumarate. Serious side effects for VUMERITY are based on data from dimethyl fumarate (which has the same active metabolite as VUMERITY) and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which is a rare opportunistic viral infection of the brain that has been associated with death or severe disability, a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. The most common adverse events, obtained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea.
About TECFIDERA® (dimethyl fumarate)
TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with TECFIDERA patients in the setting of prolonged lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the most common adverse events associated with TECFIDERA were flushing, abdominal pain, diarrhea and nausea.
About TYSABRI® (natalizumab)
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JC virus antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. 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.
Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the U.S., or visit your respective country’s product website.
About PLEGRIDY® (peginterferon beta-1a)
The efficacy and safety of PLEGRIDY are supported by one of the largest pivotal studies with interferons conducted in people living with relapsing-remitting MS. In clinical studies, PLEGRIDY has been proven to significantly reduce the rate of MS relapses, slow the progression of disability and reduce the number of MS brain lesions while demonstrating a well-characterized safety profile for patients with relapsing forms of MS. Side effects reported include liver problems, including liver failure and increases in liver enzymes; depression or suicidal thoughts; serious allergic reactions; cardiac problems, including congestive heart failure; autoimmune disorders; decreases in white blood cell or platelet counts; and seizures. In clinical trials, the most common adverse events associated with PLEGRIDY were injection site reactions and flu-like symptoms. A list of adverse events can be found in the full PLEGRIDY product labeling for each country where it is approved.
About AVONEX® (interferon beta-1a)
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.
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