The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed peginterferon-β-1a (Plegridy, Biogen Idec) for adults with relapsing-remitting multiple sclerosis (RRMS) and rejected laquinimod (Nerventra, Teva Pharma) for the same indication, after a second look at the data.
Plegridy is a pegylated interferon administered subcutaneously. The CHMP's positive opinion on the drug is largely based on the 2-year phase 3 study known as ADVANCE, which included more than 1500 patients with MS, Biogen Idec notes in a statement.
As for laquinimod, the CHMP voted against approving the drug in January 2014, as reported previouslyby Medscape Medical News. The panel noted concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to laquinimod, noting that a similar long-term risk could not be ruled out in humans. Animal data also indicated a possible risk for teratogenic effects in offspring of women taking the drug.
Fonts: Medscape
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