Alkermes plc, a fully integrated global biopharmaceutical company, recently provided a regulatory update and positive clinical trial data for ALKS 8700, an oral, innovative and proprietary monomethyl fumarate (MMF) compound that is being developed to treat multiple sclerosis (MS).
ALKS 8700 is being developed to quickly and efficiently convert to MMF in the MS patient’s body and to provide differentiated qualities in comparison with the marketed TECFIDERA®(dimethyl fumarate) currently used to treat relapsing forms of MS.
Regulatory update: Following a meeting with the U.S. Food and Drug Administration (FDA), the company is planning to submit a 505(b)(2) New Drug Application (NDA) using pharmacokinetic results from clinical studies that compared ALKS 8700 and TECFIDERA, as well as from a two-year phase 3 clinical study assessing the safety of ALKS 8700 in about 600 MS patients. This means that the company will not be obligated to conduct another phase 3 study assessing the safety of the drug in MS patients. Alkermes also plans to begin by mid-2016 a head-to-head randomized trial in which ALKS 8700 gastrointestinal (GI) tolerability will be compared to TECFIDERA in about 420 MS patients.
The company anticipates completing these clinical trials and filing the NDA in 2018.
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