Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis
December 17th, 2018
DUBLIN, Ireland and CAMBRIDGE, Mass., Dec. 17, 2018 — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS).
Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, and the NDA submission includes data from EVOLVE-1, a Phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS (RRMS) with approximately 700 patients dosed with diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITYTM. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
“Diroximel fumarate was designed to provide patients with relapsing forms of multiple sclerosis a novel oral fumarate with a differentiated profile. The data encompassed in the regulatory package underscore diroximel fumarate’s potential to be a meaningful, new treatment option for the MS community,” stated Craig Hopkinson, M.D., chief medical officer and senior vice president, medicines development and medical affairs at Alkermes. “This NDA submission is an important step in our collaboration with Biogen for diroximel fumarate, and we look forward to working together to bring this potential new medicine to patients and healthcare providers.”
“The filing of diroximel fumarate by our partners at Alkermes demonstrates our enduring commitment to people living with MS and builds on our established track record as a leader in the industry,” said Michael Ehlers, M.D., Ph.D., executive vice president, research & development at Biogen. “MS is a heterogeneous disease, and while there are a number of approved therapies available today, continued treatment advances remain an important priority.”
About the Diroximel Fumarate Clinical Development Program
The key components of the clinical development program of diroximel fumarate include the EVOLVE-MS-1 study, a two-year safety study in relapsing-remitting MS (RRMS) patients, along with pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate. In addition, Alkermes is conducting the EVOLVE-MS-2 study, a five-week, head-to-head gastrointestinal (GI) tolerability study versus dimethyl fumarate.
About Diroximel Fumarate:
Diroximel fumarate (BIIB098) is a novel oral fumarate candidate in development for the treatment of relapsing forms of MS. Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated GI tolerability due to its chemical structure as compared to dimethyl fumarate.
About Alkermes plc:
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics. We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
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