Monday, October 3, 2022


Biotechnology News Magazine

Biogen: New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS Portfolio & Emerging Research on Disease Progression

Biogen Inc. (Nasdaq: BIIB) today announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies being presented at the American Academy of Neurology (AAN) 2022 Annual Meeting. The presentations include new real-world, long-term data on TYSABRI® (natalizumab), as well as persistence and adherence learnings with VUMERITY® (diroximel fumarate).

Additional presentations highlight the use of digital tools to potentially predict MS disease progression. These data build on ongoing work to advance the understanding and treatment of serious neurological and neurodegenerative diseases, and highlight Biogen’s commitment to science that strives to address the diverse needs of people living with MS.

“Through our close work with the MS community, we have gained a strong appreciation for the diverse needs of people living with MS and continue to pursue research that is important to patients, including these new data on TYSABRI and VUMERITY,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “Additional presentations at AAN demonstrate our focus on advancing neuroscience research, including the ambitious work underway through Biogen Digital Health to identify digital health solutions aimed at improving the diagnosis and treatment of neurological conditions.”

Real-World and Clinical Trial Data Show Consistent Profile With Long-Term TYSABRI Use and Every-Six Week Administration
Two presentations contribute to the understanding of extended interval dosing (EID) with intravenous (IV) natalizumab in real-world and clinical trial settings.

  • An updated analysis of the U.S. TOUCH® (TYSABRI Outreach: Unified Commitment to Health) database as of June 30, 2021, confirms results from earlier analyses, which found that EID with IV administration of natalizumab is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) than the approved every four-week (Q4W) dosing. In the updated analysis, which included more patients and longer exposures, EID was associated with a significant 87% reduction (hazard ratio 0.127; P<0.0001) in the probability of PML in comparison to the approved Q4W dose.
  • Primary results from the Phase 3b NOVA study of every six-week (Q6W) IV dosing with natalizumab were also presented during a platform session, showing that Q6W administration of natalizumab maintains control of MS disease activity in patients who switched to Q6W after at least one year of disease stability on the approved Q4W IV dosing schedule. Topline data were first reported in August 2021, and additional results were shared at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual congress last year. The approved dose of TYSABRI is 300mg on a Q4W dosing regimen.

In addition to the data presented on Q6W IV dosing with natalizumab, a new analysis of the observational STRIVE study using the approved Q4W IV TYSABRI dosing schedule found that treatment-naïve patients with early relapsing-remitting multiple sclerosis (RRMS) had improved clinical outcomes in comparison with patients who had received prior disease-modifying therapies (DMTs). These findings provide useful information on the added clinical benefit that initiating treatment early in the disease course with TYSABRI may provide. At four years, the cumulative probability of 24-week confirmed disability worsening (CDW) was significantly lower in treatment-naïve patients than in patients with prior DMT treatment (11.5% vs 29.0%; P=0.0015).

Real-World Analyses Further Demonstrate High Rates of Persistence and Adherence for VUMERITY
In the treatment of MS, high levels of adherence and persistence with DMTs are associated with improved clinical outcomes and reduced treatment costs.1 Two claims analyses from AcariaHealth Specialty Pharmacy Program and Optum showed high rates of persistence and adherence with VUMERITY, consistent with clinical trial experience and further supporting VUMERITY as a well-tolerated oral fumarate option due to its gastrointestinal (GI) tolerability profile.

  • A retrospective analysis of the AcariaHealth Specialty Pharmacy Program included 1,143 patients who initiated therapy with VUMERITY between Dec. 1, 2019, and Jan. 30, 2021. Persistence as measured by the overall estimated proportion of patients remaining on VUMERITY at 16 months was 82.3%; 4.5% discontinued VUMERITY due to GI side effects. Adherence, as measured by proportion of days covered (PDC), was 90.8%, and 85.4% of patients achieved a PDC ≥80%. Consistent findings were also observed in a subgroup of 433 patients who switched from TECFIDERA® (dimethyl fumarate) to VUMERITY.
  • An Optum claims analysis included 1,885 patients with at least one MS-related claim between Oct. 1, 2019, and March 31, 2021: 224 were treated with VUMERITY, 746 with TECFIDERA, 601 with teriflunomide, 182 with fingolimod and 132 with siponimod. Persistence and adherence rates for VUMERITY after 90 days were 84% and 88%, respectively, consistent with or higher than those for other DMTs; 79% of patients achieved a PDC ≥80%.

Biogen Continues Pursuit of Innovation in MS With Digital Health Research
Multiple presentations support Biogen’s commitment to delivering innovative approaches to reframe the care and treatment of MS, including the development of digital tools to help refine the assessment of disease progression by using cutting-edge computer vision applied to brain magnetic resonance imaging (MRI) scans. Several abstracts highlight early work using machine learning to predict MS lesion formation and detect slowly expanding lesions (SELs). This research is designed to help better understand MS disease heterogeneity by unravelling the mechanisms of acute lesion formation and chronic lesion evolution, which could in the future help inform clinical trial design and, ultimately, improve patient care.

“This is an exciting time in MS research as we see the confluence of medical and computational science,” said Shibeshih Belachew, M.D. PhD., Head of Science, Biogen Digital Health. “These presentations on novel medical image computing tools and advanced algorithmic solutions provide an early vision for predicting disease progression, driving even greater steps toward more precise and personalized care of people living with MS.”

Data Presentations Featured at AAN:

  • Natalizumab Extended Interval Dosing (EID) Is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-Week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database – P13.010 – Wednesday, April 6, 8-9 a.m. PDT
  • Primary Results of NOVA: a Randomized Controlled Study of the Efficacy of 6-Week Dosing of Natalizumab Versus Continued 4-Week Treatment for Multiple Sclerosis – S14.005 – Monday, April 4, 4:18-4:30 p.m. PDT
  • Effectiveness of Natalizumab Treatment in Patients with Early Relapsing-Remitting Multiple Sclerosis (RRMS) Who Were Treatment-Naive Versus Those Who Had Prior Disease-Modifying Therapy (DMT) Use – P6.006 – Sunday, April 3, 5:30-6:30 p.m. PDT
  • Updated Real-World Analysis Affirms the High Persistence and Adherence Observed with Diroximel Fumarate in Patients with Multiple Sclerosis – P9.007 – Monday, April 4, 5:30-6:30 p.m. PDT
  • Diroximel Fumarate (DRF) Has High Rates of Real-World Adherence and Persistence in Patients with Multiple Sclerosis (MS): Retrospective Claims Analysis – P9.008 – Monday, April 4, 5:30-6:30 p.m. PDT
  • Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Interim Safety and Efficacy Results from the Phase 3 EVOLVE-MS-1 Study – P7.008 – Monday, April 4, 8-9 a.m. PDT
  • Machine Learning-Based Detection of Slowly Expanding Lesions Using Radiomic Features from Cross-sectional Brain MRI – S26.004 – Wednesday, April 6, 1:36-1:48 p.m. PDT
  • Machine Learning-Based Prediction of New Multiple Sclerosis Lesion Formation Using Radiomic Features from Pre-Lesion Normal Appearing White Matter – S26.009 – Wednesday, April 6, 2:36-2:48 p.m. PDT
  • Exploring the Utility of MRI-Based ‘SuStaIn’ Disease Subtyping for Precision Medicine in Relapsing and Secondary Progressive MS – P15.002 – Wednesday, April 6 at 5:30-6:30 p.m. PDT

About TYSABRI® (natalizumab)
TYSABRI is a well-established relapsing multiple sclerosis (RMS) treatment indicated for relapsing forms of MS in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. TYSABRI is approved in 80 countries, and over 240,000 people worldwide have been treated with TYSABRI, with over 970,000 patient-years of experience, based on clinical trials and prescription data.2

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), 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 an oral fumarate with a distinct chemical structure from TECFIDERA® (dimethyl fumarate), approved in the U.S. for the treatment of relapsing forms of multiple sclerosis in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate. VUMERITY is approved in more than 30 countries, and more than 20,000 patients have been treated with it, representing more than 15,000 patient-years of exposure across clinical trial use and patients prescribed VUMERITY. 3

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.


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