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In May 2016, the Food and Drug Administration (FDA) gave a green signal to Zinbryta—AbbVie Inc.’s (NYSE:ABBV) and Biogen’s mutually-developed molecule molecule—to manage and treat adult patients who suffer from different relapsing ailments of Multiple Sclerosis (MS). In July 2016, the European Commission (EC) approved it for marketing and commercialization in the European countries. The drug is now available in the US therapeutic market.
The regulatory agencies have given the drug an approval based on the scientific data, which showed that it has met primary endpoints in relation to the efficacy and safety profile in two clinical trials. These were the SELECT study and DECIDE study, which aimed to treat MS.
In this regard, AbbVie chief scientific officer and EVP of research and development (R&D) Michael Severino commented: “With the approval of ZINBRYTA in the European Union, we are providing a much-needed treatment option for people living with MS. […] This is an important part of AbbVie’s ongoing commitment to advancing neuroscience research specifically in the area of MS.”
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