Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis - Seite 2

"Diroximel fumarate demonstrated statistically superior GI tolerability compared to dimethyl fumarate on the EVOLVE-MS-2 study's primary endpoint, as well as a low discontinuation rate of less than 1% due to GI adverse events. These results reinforce the safety and tolerability profile diroximel fumarate has consistently demonstrated across the EVOLVE-MS development program, underscoring the potential importance of diroximel fumarate for the treatment of people living with relapsing-remitting MS. We look forward to the FDA's completion of its review of the diroximel fumarate NDA in the fourth quarter," said Craig Hopkinson, M.D., chief medical officer and senior vice president of medicines development and medical affairs at Alkermes.

EVOLVE-MS-2 was a Phase 3, multicenter, double-blind, active-controlled, five-week study designed to evaluate the GI tolerability, including duration and severity, of diroximel fumarate 462 mg twice daily compared to dimethyl fumarate 240 mg twice daily in 506 patients with RRMS. The study's primary endpoint assessed the number of days patients reported GI symptoms with a symptom intensity score ≥2 on the IGISIS rating scale spanning 0 (not at all) through 10 (extreme). The IGISIS was completed twice daily and evaluated the intensity of key GI symptoms, including nausea, vomiting, upper and lower abdominal pain, and diarrhea.

"With a chronic disease like MS, interrupting or stopping treatment due to GI side effects can often provoke the return of disease activity. Physicians and patients should work together to choose a medication that provides the right balance of efficacy, safety and tolerability to help manage patients' MS and meet their treatment goals," said Robert Naismith, M.D., professor of neurology, Washington University School of Medicine in St. Louis. "These topline results suggest that diroximel fumarate offers a differentiated GI tolerability profile and may represent an important new option for people living with relapsing MS."

The EVOLVE-MS-2 study is part of the EVOLVE-MS diroximel fumarate clinical development program, which is being conducted as part of a worldwide development and commercialization agreement between Alkermes and Biogen. Diroximel fumarate is currently under review with the U.S. Food and Drug Administration (FDA) with a PDUFA (Prescription Drug User Fee Act) target action date in the fourth quarter of 2019. Biogen intends to market diroximel fumarate under the conditionally approved brand name VUMERITY.