EXTON, Pa.--(BUSINESS WIRE)--While Biogen Idec’s Avonex and Teva’s Copaxone continue to capture the majority of multiple sclerosis (MS) patients first starting on a disease-modifying agent (DMA), the introduction of Novartis’ Gilenya, the only oral DMA currently on the market, appears to have impacted the average length of the time that patients remain on their first-line therapy before a switch may be initiated. Gilenya, typically prescribed as a second or later-line DMA, has also negatively impacted the overall market share of certain DMAs compared to the 2010 audit fielded prior to the Gilenya launch, with Pfizer / EMD Serono’s Rebif and Biogen Idec’s Avonex, taking the greatest hit.
In addition to the introduction of Gilenya, another recent event impacting the MS market is the commercial availability of the anti-JC virus antibody assay to help mitigate the PML risk associated with treatment of Biogen Idec’s Tysabri. Based upon the patient-level audit data, the percent of patients tested for anti-JC virus antibodies differs based both on brand of DMA at the time of testing and MS disease classification. While patients who test negative for the antibodies are most likely to switch to Tysabri, patients who test positive are most likely to switch to Gilenya.
The majority of DMA-treated patients experience at least some MS-related symptoms with the most common including fatigue, abnormal sensory perceptions, and balance issues. Since there are currently very few FDA-approved symptomatic agents, the agents most often prescribed to help control MS-related symptoms are typically products without a formal indication for MS. Acorda's Ampyra, the first FDA-approved symptomatic agent for a MS-related symptom, is used by neurologists to treat walking impairment, spasticity, and / or fatigue. A number of important differences exist between patients treated with Ampyra and those who are not, including the severity of the disease at DMA initiation and current disease classification.
When asked to hypothetically switch audit patients to one of the DMAs in late stage clinical development, neurologists identify the greatest opportunity for Biogen Idec’s PEG-Avonex and Teva’s laquinimod. A number of patient characteristics appear to help identify the types of patients who are perceived by neurologists as more likely to be switched to a specific DMA in development upon approval.
ChartTrends®: Multiple Sclerosis is a syndicated annual patient audit designed to compare what physicians self-report about disease management to what actually occurs at the patient level. The 2011 audit captures information from 1088 patient charts provided by 223 U.S. neurologists in September 2011. All audit patients are on a DMA at the time of the audit with all DMA-brands (Avonex, Betaseron, Copaxone, Extavia, Gilenya, Rebif, Tysabri) represented. A parallel report covering the European market (EU5) is also available. Through an in-depth review of specific patient charts, details such as product initiation, switching, concomitant medications, exacerbation management, and a host of test and patient demographic variables help define patient types and identify therapy triggers. Patient profiles for the seven DMAs in late clinical development (alemtuzumab, BG-12, teriflunomide, laquinimod, PEG-Avonex, daclizumab, ocrelizumab) are also characterized.
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