News|Articles|October 9, 2015

MS drugs make major advancements

There is new hope for patients with multiple sclerosis (MS) after positive data on Gilenya and the investigational drug ocrelizumab was presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

There is new hope for patients with multiple sclerosis (MS) after positive data on Gilenya and the investigational drug ocrelizumab was presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

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Genentech, a member of the Roche group, shared data from 3 positive, pivotal phase 3 studies of ocrelizumab in people with relapsing MS and primary progressive MS (PPMS).

Data from 2 identical studies (OPERA I and OPERA II) in people with relapsing MS, which affects approximately 85% of people with MS at the time of diagnosis, showed ocrelizumab was superior to interferon beta-1a (Rebif), a well-established MS therapy, in reducing the 3 major markers of disease activity over the 2-year controlled treatment period.

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“Ocrelizumab is the first investigational medicine to significantly reduce disability progression in people with relapsing MS and people with primary progressive MS – a form of MS with no approved treatments,” said Sandra Horning, MD chief medical officer and head of global product development for Genentech. “We are eager to work with regulatory authorities to bring this investigational medicine to the MS community as soon as possible.” 

In addition, Novartis said its 2 phase 3 trials reinforced the long-term efficacy profile of Gilenya (fingolimod). The analysis evaluated the proportion of Gilenya patients with relapsing multiple sclerosis (RMS), achieving ‘no evidence of disease activity’ (NEDA-4) every year over 7 years.

In the first year, 27.1% of patients on Gilenya achieved NEDA-4 compared to 9.1% on placebo. Switching from placebo to Gilenya after year 2 doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year 3. Of those patients on continuous Gilenya treatment, 31.2% to 44.8% had NEDA-4-status in each of the years 3 to 7.

A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials also confirmed for the first time that assessment of RMS based on NEDA-4 allowed physicians to better predict long-term disability and brain shrinkage outcomes than just assessing relapses, MRI lesions and disability progression.

 

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