Alkermes PLC, a Dublin-based biotechnology company, and its partner Biogen Inc. have submitted a new drug application to the U.S. Food and Drug Administration seeking approval to market its multiple sclerosis treatment BIIB098.
MS is a chronic disorder that affects the brain and spinal cord, causing problems with vision, arm or leg movement, sensation or balance. In relapsing-remitting multiple sclerosis, patients experience flare-ups or relapses of the disease's symptoms. Between flare-ups, patients have periods of partial or complete recovery, called remission.
The drug application, announced Dec. 17, includes data from a phase 3 trial, Evolve-MS-1, which is evaluating the long-term safety of BIIB098, also known as diroximel fumarate, in about 700 patients with relapsing-remitting forms of MS. It is a two-year, open-label study expected to end in December 2020.
Alkermes has started enrolling participants in a five-week head-to-head study, Evolve-MS-2, which will compare BIIB098 against Biogen's Tecfidera, or dimethyl fumarate, for gastrointestinal tolerability in patients with relapsing-remitting multiple sclerosis. Complete results from the phase 3 trial are expected in June 2019.
Alkermes licensed the development and commercial rights of BIIB098, formerly known as ALKS 8700, to Biogen in November 2017. Alkermes maintained the responsibility for regulatory interactions with the FDA.