ALKS 8700 advances comparison studies with Tecfidera (dimethyl fumarate) in MS- Alkermes
Based on a meeting with the FDA, Alkermes plans to file a 505(b)(2) New Drug Application (NDA) using pharmacokinetic bridging data from studies comparing ALKS 8700 and Tecfidera (dimethyl fumarate) as well as a two-year phase III safety study of ALKS 8700 in approximately 600 patients with MS. Importantly, this means that Alkermes will not be required to conduct a separate phase III efficacy study in patients with MS.
In addition, Alkermes intends to initiate a randomised head-to-head study comparing the gastrointestinal (GI) tolerability of ALKS 8700 and dimethyl fumarate in approximately 420 patients with MS in mid-2016. Alkermes expects to complete these studies and file the NDA in 2018.
Comment: ALKS 8700 showed less variability and improved gastrointestinal tolerability compared with diethyl fumarate, according to top-line results from a recent trial.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.