A drug under consideration by the Food and Drug Administration for multiple sclerosis has shown superiority in terms of gastrointestinal tolerability over its comparator. But while analysts said the drug will likely win FDA approval, it is uncertain if the latest data will drive significant uptake, especially with the comparator’s anticipated availability as a generic.

Cambridge, Massachusetts-based Biogen and Dublin-based Alkermes said Tuesday morning that in the Phase III EVOLVE-MS-2 study, Vumerity (diroximel fumarate) showed statistically significant superiority in gastrointestinal symptoms over Biogen’s Tecfidera (dimethyl fumarate).

The study, which enrolled 506 patients randomized to receive either Tecfidera or Vumerity, also known as ALKS 8700, was primarily designed to evaluate the latter drug’s gastrointestinal tolerability.

“With a chronic disease like MS, interrupting or stopping treatment due to GI side effects can often provoke the return of disease activity,” said Washington University in St. Louis neurologist Dr. Robert Naismith, in a statement on behalf of the company. “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.”

With Tecfidera, the most common side effects include abdominal pain, diarrhea and nausea, according to the drug’s package insert. Diarrhea and nausea were also among the common side effects with Vumerity, though they occurred at a lower rate than with Tecfidera in the study: 15.4 and 14.6 percent, respectively, compared with 22.3 percent and 20.7 percent for the control group. In terms of flushing, the drugs respectively showed rates of 32.8 percent and 40.6 percent.

In a note to investors Tuesday, Cowen analyst Phil Nadeau wrote that the demonstration of a better gastrointestinal tolerability profile for Vumerity was encouraging – particularly as another study, EVOLVE-MS-1, also showed a benign side effect profile – and that analysts are hopeful the drug will win FDA approval in the fourth quarter of this year. The FDA accepted Biogen and Alkermes’ approval application for the drug in February.

However, he wrote, while the differences in toxicity rates are notable, it is questionable whether they will be substantial enough for physicians and payers to prefer Vumerity over generic versions of Tecfidera. Meanwhile, it was suspected that most patients on Tecfidera tolerate the drug and are thus unlikely to switch to Vumerity, assuming Tecfidera generics hit the market in 2023.

“Therefore, our analysis assumes Vumerity does not meaningfully protect the Tecfidera franchise from generic competition,” Nadeau wrote. Tecfidera is Biogen’s top-selling drug, with $1.15 billion in sales during the second quarter of this year, according to financial results announced last week.

Photo: John Tlumacki, The Boston Globe via Getty Images



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