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Biogen & Alkermes' multiple sclerosis drug proves "statistically superior" to Tecfidera at Phase 3

Published on 31/07/19 at 12:37pm

Biogen and Alkermes have unveiled new Phase 3 data for diroximel fumarate, comparing the adequacy of the therapy to Biogen’s own Tecfidera (dimethyl fumarate) in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

The Phase 3 study sought to determine the gastrointestinal tolerability, including duration and severity, of diroximel fumarate 462mg twice daily compared to Tecfidera 240mg twice daily, with a primary endpoint measuring the intensity and number of days that gastrointestinal symptoms were experienced.

The findings stated that diroximel fumarate was “statistically superior” in terms of gastrointestinal tolerability compared to Tecfidera, with trial participants self-reporting fewer days of gastrointestinal symptoms, as well as intensity scores of ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS).

“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,” explained Dr Craig Hopkinson, Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. “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.”

Biogen’s Michael Ehlers, Executive Vice President, Research & Development, also remarked: “As part of our leadership in multiple sclerosis, Biogen has long understood that the disease differs from person to person, as well as throughout the course of the disease. We are committed to offering a range of options to patients to meet their needs. These data build on the foundation we have created with Tecfidera, the most prescribed oral MS therapy worldwide, and further demonstrate the potential of diroximel fumarate as a novel oral fumarate within our MS portfolio.”

Diroximel fumarate is currently awaiting review from the FDA with a decision due in the fourth quarter of 2019. Should it be approved, Biogen has said it will be marketed under the brand name Vumerity.

Matt Fellows

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