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Biogen shows meds effective against relapsing MS

April 24, 2017

Biogen (NASDAQ: BIIB) announced new real-world data that show treatment with its leading multiple sclerosis (MS) therapies, TECFIDERA® (dimethyl fumarate) and TYSABRI® (natalizumab), early in the course of the disease may improve outcomes for people living with relapsing MS. These data were presented at the 69th annual meeting of the American Academy of Neurology (AAN) in Boston.

MS is a chronic, often disabling disease that attacks and causes inflammation within the central nervous system. Initiating an appropriate disease modifying therapy soon after diagnosis has been shown to slow the physical and cognitive decline associated with MS and may prevent the accumulation of future disability, allowing people living with MS to stay active longer.1,2

“The new real-world TECFIDERA and TYSABRI data presented at AAN emphasize the importance of effective treatment early in the course of one’s disease,” said Kate Dawson, M.D., vice president, U.S. Medical at Biogen. “Timely treatment with appropriate therapies can help mitigate damage caused by MS and delay long-term disability for people with the disease.”

Comparative Effectiveness Data Further Support Use of TECFIDERA in Early MSTECFIDERA is the world’s most prescribed oral therapy for MS. A comparison of real-world data provides further evidence of its strong efficacy relative to other oral MS therapies, both in newly-treated MS patients and those previously treated with a prior disease modifying therapy (DMT). Researchers used U.S. insurance claims data to compare the time to first relapse among patients initiating TECFIDERA versus fingolimod or teriflunomide. These results show that TECFIDERA significantly reduced the risk of relapse by 30 percent compared to teriflunomide (hazard ratio [HR]: 1.302; p<0.01) in newly diagnosed patients and those previously treated with a prior DMT, and had comparable efficacy to fingolimod (HR: 0.995; p=0.94). These data are consistent with other comparative effectiveness data showing similar results to oral therapies and greater efficacy to interferon beta and glatiramer acetate.

Subgroup analyses of the open-label studies PROTEC and RESPOND assessed TECFIDERA in early MS and early switch patients, respectively. Results show that TECFIDERA significantly reduced the annualized relapse rate (ARR) over one year in the early MS subgroups, including those who switched to TECFIDERA from a prior DMT. Additional data presented at the meeting affirm the well-characterized, long-term safety profile of TECFIDERA in patients treated for up to nine years.

Early and Continued TYSABRI Treatment Leads to Better Outcomes in MS Patients with High Disease ActivityTYSABRI is the only targeted high-efficacy MS treatment with more than 10 years of clinical experience. New data from the TYSABRI Observational Program (TOP) reinforce the proven efficacy of TYSABRI and demonstrate that early and continued treatment leads to better clinical outcomes.

A subgroup analysis from TOP compared outcomes for treatment-naive patients who began taking TYSABRI shortly after MS symptom onset (≤1 year) with those who initiated TYSABRI after experiencing MS symptoms for some time (>1 and ≤5 years, or >5 years). Annualized relapse rate and disability worsening or improvement, as measured by the Expanded Disability Status Scale (EDSS), were assessed. Results show that, over three years, the likelihood of disability improvement was significantly greater for patients treated with TYSABRI within one year of MS symptom onset (49.3%), than for those treated between one to five years (38.1%) or more than five years (26.3%) following symptom onset. TYSABRI treatment also significantly reduced ARR compared with baseline in all three cohorts. Additional TOP data presented at the meeting show patients who continued TYSABRI treatment experienced better clinical outcomes than those who switched to another therapy.

Select TECFIDERA Data Presentation Details:

  • Comparative Effectiveness of Delayed-release Dimethyl Fumarate Versus Fingolimod and Teriflunomide on Risk of Relapse – Poster P6.375 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Comparative Analysis of MS Outcomes in Dimethyl Fumarate-treated Patients Relative to Propensity Matched Fingolimod, Interferon, Glatiramer Acetate, or Teriflunomide – Poster P6.372 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Effectiveness of Delayed-release Dimethyl Fumarate on Clinical Measures and Patient-reported Outcomes in Newly Diagnosed and Other Early Relapsing-remitting Multiple Sclerosis Patients: Subgroup Analysis of PROTEC – Poster P6.363 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Effectiveness of Delayed-release Dimethyl Fumarate on Clinical Measures and Patient-reported Outcomes in Relapsing Multiple Sclerosis (RMS) Patients Switching After Suboptimal Response to Glatiramer Acetate, Including Patients with Early MS: Subgroup Analysis of RESPOND – Poster P2.406 – Monday, April 24, 8:30 a.m. – 7:00 p.m. ET
  • Safety of Delayed-release Dimethyl Fumarate in Relapsing-remitting Multiple Sclerosis Patients from ENDORSE: Seven-year Interim Results – Poster P5.383 – Thursday, April 27, 8:30 a.m. – 7:00 p.m. ET

Select TYSABRI Data Presentation Details:

  • In Treatment-naive Patients with Relapsing-remitting Multiple Sclerosis (RRMS), Initiating Natalizumab Earlier is Associated with Greater Disability Improvement than Delaying Treatment: Real-world Results from the TYSABRI® Observational Program (TOP) – Poster P6.350 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Real-world Relapsing-remitting Multiple Sclerosis (RRMS) Patients in the TYSABRI® Observational Program (TOP) Who Discontinued Natalizumab: Why They Stopped, Which Therapies They Switched to, and How Their Disease Activity Changed – Poster P2.399 – Monday, April 24, 8:30 a.m. – 7:00 p.m. ET

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