Drug Overview
ALKS 8700 is an oral monomethyl fumarate molecule being developed for the treatment of relapsing multiple sclerosis. Alkermes designed this drug to have Tecfidera-like efficacy, but to also display superior gastrointestinal tolerability. After being administered, ALKS 8700 rapidly metabolizes into monomethyl fumarate. While the actual mechanism of monomethyl fumarate is unknown, the molecule has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 pathway, which is involved in the cellular response to oxidative stress.
ALKS 8700 is currently in the middle of its pivotal Phase III clinical trial program, with Alkermes planning to submit a 505(b)(2) New Drug Application in 2018.
TABLE OF CONTENTS
4 Product Profiles
4 ALKS 8700 : Multiple sclerosis (MS)
LIST OF FIGURES
7 Figure 1: ALKS 8700 for multiple sclerosis – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary of ALKS 8700 for multiple sclerosis
9 Figure 3: Datamonitor Healthcare’s drug assessment summary of ALKS 8700 for multiple sclerosis
11 Figure 4: ALKS 8700 sales for multiple sclerosis across the US and five major EU markets, by country, 2016–25
LIST OF TABLES
5 Table 1: ALKS 8700 drug profile
6 Table 2: ALKS 8700 Phase III trials in multiple sclerosis
12 Table 3: ALKS 8700 sales for multiple sclerosis across the US and five major EU markets, by country ($m), 2016–25