03-03-2014 09:41 Biogen Idec Norway AS ? Five-year interim analysis from the TYSABRI Observational Program confirmed TYSABRI Overall Safety ? Analysis Showed TYSABRI Use Earlier in the Course of RRMS Treatment Reduced Clinical Disease Activity; Low Probability of Disease Progression Also Demonstrated
[Oslo, Norway] ?February 17, 2014? Biogen Idec (NASDAQ: BIIB) today announced TYSABRI? (natalizumab) data published online in the Journal of Neurology, Neurosurgery, and Psychiatry confirmed its safety profile and demonstrated a low probability of relapse and a low rate of confirmed Expanded Disability Status Scale (EDSS) progression at five years in patients with relapsing-remitting multiple sclerosis (RRMS). The new five-year interim analysis from the TYSABRIObservational Program (TOP), an ongoing observational, open-label, 10-year prospective study, assessed patients who have been treated with TYSABRI for RRMS in a clinical practice setting. ?This analysis provides important evidence in clinical practice that establishes TYSABRI?s long-term safety profile and its positive impact on the key clinical measures of MS disease activity, annualized relapse rate and disability progression,? said Helmut Butzkueven, M.D., TOP Steering Committee member, director at Eastern Health MS Service, and associate professor at the University of Melbourne. ?These findings are encouraging for patients and physicians who are seeking treatment options that may significantly delay disease progression in this chronic disease and better assess the risks and benefits of long-term treatment.? Study Results This interim analysis indicates that TYSABRI demonstrated a safety profile that was consistent with previous studies and no new safety concerns were identified in a clinical practice setting. 2.6 percent of patients experienced a serious adverse event considered related, or possibly related, to treatment with TYSABRI. The most common serious adverse event was infection (1.9%). The mean on-treatment annualized relapse rate (ARR) was significantly reduced (from 1.99 at baseline to 0.31 at one year) and remained low at five years of TYSABRI exposure. While patients treated with TYSABRI had significant reductions in ARR regardless of treatment history, ARRs were lowest in patients who were therapy na?ve and had lower EDSS scores at baseline and highest in those patients with prior immunosuppressant use. On-treatment EDSS scores remained stable over time, and the probability of confirmed EDSS improvement was significantly higher than the probability of confirmed worsening (29 percent compared to 16 percent (p<0.0001) in patients with EDSS scores >2.0 at baseline). ?TYSABRI has advanced the treatment of RRMS with its established efficacy and we remain committed to studying TYSABRI use over the long term,? said Associate Director Medical Affairs Glenn Gundersen ?These new results describe the potential clinical value of TYSABRI when taken earlier in the course of disease, as well as when taken for an extended period of time, and continue to support the benefit of TYSABRI for RRMS patients who need its proven efficacy.? About TOP The TYSABRI? (natalizumab) Observational Program (TOP) is an ongoing, open-label, multinational, multicenter, 10-year prospective, observational study conducted in clinical practice settings in 16 countries across Europe, Australia, Canada, and Argentina. Patients receive TYSABRI 300 mg intravenously every four weeks. TOP was designed to evaluate the long-term safety of TYSABRI monotherapy, as well as its impact on disease activity and disability progression, in patients with RRMS in the clinical practice setting. Data published in the Journal of Neurology, Neurosurgery, and Psychiatry presents findings from an interim analysis of TOP data from study initiation in July 2007 to a data lock on December 1, 2012. About TYSABRI TYSABRI is approved in more than 65 countries. In the European Union (Norway included), it is indicated as a single disease modifying therapy in highly active relapsing-remitting MS (RRMS) for adult patients who have high disease activity despite treatment with a beta interferon or glatiramer aate or patients with rapidly evolving severe RRMS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. About Biogen Idec Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for serious diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com/. Biogen Idec er et globalt bioteknologiselskap hvor vi gjennom moderne biomedisinsk forskning oppdager, utvikler, produserer samt markedsf?rer biologiske legemidler for behandling av alvorlige sykdommer med fokus p? nevrologiske lidelser. For v?re pasienter, er vi en kilde til viktig behandling for multippel sklerose (MS), med v?re produkter AVONEX? (inteferon beta – 1a), Fampyra? (fampridin)og TYSABRI? (natalizumab).