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Delayed-release oral capsules for various forms of the disease.
The FDA has approved diroximel fumarate (Vumerity, Biogen Inc and Alkermes plc) delayed-release oral capsules for the treatment of clinically isolated multiple sclerosis (MS), relapsing-remitting disease, and active secondary progressive disease, in adults.
"The approval of Vumerity for relapsing MS marks the culmination of a multi-year development program and is the latest milestone in our mission to develop new treatments for patients living with chronic central nervous system disorders," said Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, in a statement. "We are grateful to the patients and study investigators who have participated in our Vumerity clinical trials and we look forward to working with our collaboration partners at Biogen to make this new treatment available to patients
The approval, according to a release, was granted based on a new drug application (NDA) that included data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera. The NDA established bioequivalence and relied on FDA safety and efficacy findings of Tecfidera.
The NDA submission also included interim data from an ongoing, phase 3, single-arm, open-label, two-year safety study (Evolve-MS-1) evaluating Diroximel fumarate in patients with relapsing-remitting MS. Diroximel fumarate has shown lower overall rates of treatment discontinuation due to adverse events (6.3%). Those patients that did discontinue treatment (less than 1%) did so due to adverse gastrointestinal events.
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"MS is a heterogeneous disease, and real-world patient circumstances can vary, reinforcing the benefits of having therapeutic choices to support the diverse range of treatment considerations," said Robert Naismith, MD, professor of neurology, Washington University School of Medicine in St. Louis, in a statement. "Throughout its clinical development program, Vumerity has demonstrated a desirable therapeutic profile, making it a compelling new option for patients."
Diroximel fumarate is contraindicated in patients with known hypersensitivity to the molecule, dimethyl fumarate, or any of Vumerity’s excipients. Diroximel fumarate is also contraindicated for co-administration with dimethyl fumarate.
Warnings and precautions issued with diroximel fumarate’s prescribing information include anaphylaxis and angioedema; progressive multifocal leukoencephalopathy; lymphopenia; and liver injury.
Adverse events reported with the use of diroximel fumarate include flushing, abdominal pain, diarrhea, and nausea.