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New Data at AAN 2021 from Across Biogen's MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis
CAMBRIDGE, Mass., April 16, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies to be presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting, April 17-22. The presentations include data on quality of life benefits and analyses of extended interval dosing (EID) with TYSABRI® (natalizumab) as well as new real-world experience data from VUMERITY® (diroximel fumarate). The research adds to the vast clinical knowledge Biogen continues to advance as part of its commitment to the care of people living with MS. “With chronic conditions like MS, where every patient has a different experience with the disease, it is critically important to understand how treatment impacts their daily living and quality of life,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “These data show that the benefits TYSABRI provides in terms of a patient’s quality of life are substantial and that the positive gastrointestinal tolerability profile of VUMERITY can help people with relapsing MS continue with treatment, which is essential to delay its progression.” Analyses Demonstrate Improved Quality of Life Outcomes with TYSABRI and Further Evaluate Extended Interval Dosing
Neuro-QoL is an independently validated set of patient-reported outcome measurements that assess the physical, mental and social effects of people living with neurological conditions such as MS. Biogen established the MS PATHS network to foster collaboration between leading MS centers in Europe and the U.S. to help transform patient care by generating standardized data from a diverse, real-world patient population. Additionally, results from two new analyses investigating EID with natalizumab may help further inform the drug’s benefit-risk profile. Biogen continues to evaluate the efficacy, safety and tolerability of natalizumab EID through the prospective NOVA trial (NCT03689972) with initial results expected in 2021.
Data Confirm Positive Gastrointestinal Tolerability Profile With VUMERITY in Real-World Setting Biogen Continues Leading Research in MS Data Presentations Featured at AAN:
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 incease 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), a decrease in lymphocyte counts 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 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. Please click here for Important Safety Information and full Prescribing Information, including Patient Information for VUMERITY in the U.S. 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. Please click here for Important Safety Information and full Prescribing Information, including Patient Information for TECFIDERA 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; injection site reactions, cardiac problems, including congestive heart failure; blood problems, such as decreases in white blood cell or platelet counts; autoimmune disorders; 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. PLEGRIDY can be considered for use in relapsing MS patients throughout the full course of pregnancy and during breast-feeding, if clinically needed. Please click here for Important Safety Information and full Prescribing Information, including Medication Guide for PLEGRIDY in the U.S., or visit your respective country’s product website. About Biogen We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media Twitter, LinkedIn, Facebook, YouTube. Biogen Safe Harbor These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; risks of unexpected costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. References:
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