On May 23, 2014, Biogen Idec received good news as EMA-CHMP released a positive opinion for the marketing authorization of Plegridy, a pegylated interferon administered by subcutaneous injection once every two weeks at a dose of 125 mcg for adults with RRMS. Plegridy offers a less frequent dosing schedule among the interferon class of treatments for MS. The most common side effects include injection site erythema, influenza-like illness, pyrexia (fever), headache, myalgia (muscle pain), chills, injection site pain, asthenia (weakness), injection site pruritus (itching), and arthralgia (joint pain). Plegridy is being developed by Biogen Idec who also markets Tecfidera, Avonex, Tysabri, Fampyra, and Rituxan.
In the phase III ADVANCE study involving more than 1500 people with RRMS, Plegridy demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo. Data from the first year of the study demonstrated that Plegridy significantly reduced annualized relapse rate (ARR) at one year by 36%, reduced the risk of 12-week confirmed disability progression by 38%, and significantly reduced the number of new or newly enlarging T2-hyperintense lesions when compared to placebo. The ADVANCE two-year data was consistent with the positive efficacy and safety results observed in year one.
In other research news:
A new study shows that diets that are lower in magnesium and folate are correlated with higher fatigue scores in multiple sclerosis patients.
Researchers studying stem cell rejection following transplantation discovered that mice infected with the neurotropic JHM strain of mouse hepatitis virus (JMHV) who were injected with human neural precursor cells (hNPCs) derived from human embryonic stem cells (hESCs) experienced improved motor skills and a reduction in neuroinflammation and demyelination about two weeks after the injections. Mice who had been paralyzed regained the ability to walk. Further studies are warranted.
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Hot Topics and MS Research News for May 2014