TMCnet News
New Research Demonstrate Biogen's Continued Commitment to Improve Care of Patients with Multiple Sclerosis Across Treatment Spectrum
CAMBRIDGE, Mass., Sept. 12, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) is highlighting new data that demonstrate the potential benefits of treatment with TYSABRI® (natalizumab), PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a) in specific multiple sclerosis (MS) patient populations. Results obtained in real-world clinical practice are being presented at the 35th Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and 24th Annual Conference of Rehabilitation in MS in Stockholm (September 11-13). “Biogen’s long-standing leadership in MS presents an opportunity to continue evolving the paradigm of care through continued research of some of our most widely prescribed MS therapies, including TYSABRI, PLEGRIDY and AVONEX,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “Through thoughtful and rigorous exploration of potential new approaches, like TYSABRI extended interval dosing, we are working to optimize patient outcomes.” Data Further Support Early Treatment with TYSABRI and Extended Interval Dosing The effectiveness of every six weeks (Q6W) dosing with natalizumab was evaluated using data from the TYSABRI Observational Program (TOP), an ongoing, real-world study of natalizumab-treated patients. Analyses compared relapse outcomes in patients who switched to natalizumab Q6W dosing after at least one year on every four weeks (Q4W) dosing (n=135) to those who remained on the approved Q4W dosing (n=135). After propensity score matching, results indicate there was no significant difference in annualized relapse rate or risk of relapse between the two groups. These data complement the previously presented TOUCH database safety analysis showing that natalizumab extended interval dosing (EID; average of approximately six weeks) was associated with a significantly lower risk of the rare but serious brain infection progressive multifocal leukoencephalopathy (PML), compared to Q4W dosing. Biogen recently completed enrollment for the Phase 3b NOVA study, a two-year, randomized, prospective trial that will compare the effectiveness of natalizumab Q4W versus Q6W after at least one year of Q4W dosing. Real-world Data Indicate Interferon Beta Treatment May Not Impact Some Pregnancy/Infant Outcomes Researchers utilized healthcare data from Nordic registers (Finland and Sweden) to retrospectively analyze infant outcomes for women with MS treated with interferon beta compared to women with MS unexposed to disease-modifying therapies. Results show outcomes were similar between the two groups, with no evidence that exposure to interferon beta treatment before and/or during pregnancy affected the weight or head circumference of infants at birth. Data on pregnancy outcomes collected during the ongoing five-year PLEGRIDY Observational Program (POP), which is evaluating the long-term safety and effectiveness of PLEGRIDY in more than 1,200 relapsing MS patients worldwide, were consistent with previously reported pregnancy outcomes from both the Nordic registers study and the European Interferon Beta Pregnancy Registry. Featured data presentation details:
About TYSABRI® 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. TYSABRI also increases the risk of developing encephalitis ad 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® The efficacy and safety of PLEGRIDY is supported by one of the largest pivotal studies with interferons conducted in people living with RRMS. 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 favorable 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. 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 AVONEX® 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. Please click here for Important Safety Information and full Prescribing Information, including Medication Guide for AVONEX 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. To learn more, please visit www.biogen.com and 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; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our products and expansion of product labeling; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; and product liability claims. 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.
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