Novartis gets a green light to challenge Roche, Sanofi with delayed MS med Kesimpta

Novartis
Novartis' Kesimpta won FDA approval after regulators in June announced a three-month delay to their review. (Novartis)

Back in June, the FDA delayed its decision deadline for Novartis’ multiple sclerosis prospect ofatumumab by three months. But it turns out the agency didn’t need that long after all.

U.S. regulators Thursday cleared the drug, which will go by the name Kesimpta, in relapsing forms of MS, including relapsing-remitting disease and secondary progressive disease. It’ll bear a list price of $83,000, making it “one of the lowest-cost branded (disease-modifying therapies),” a company spokesman said by email, adding that the drug “is priced competitively to reflect its unique value and to ensure broad access.”

Speaking of competition, Kesimpta will have plenty. The drug, which targets CD20-expressing B cells—and is already approved as Arzerra in leukemia—is joined in that department by Sanofi’s Aubagio and Roche’s Ocrevus, a fast-growing behemoth in the MS field. And that’s not to mention Zeposia, a recent Bristol Myers Squibb launch that’s part of an S1P modulator group that also includes Novartis’ own Mayzent and Gilenya.

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RELATED: Novartis' repurposed leukemia drug tops Sanofi's Aubagio in MS study weeks ahead of FDA verdict

But Novartis isn’t worried. “Despite this being a crowded space, we believe that there’s still a significant unmet need,” Victor Bultó, Novartis’ U.S. pharma president, said ahead of the green light. According to Novartis’ findings, about half of patients “basically signal dissatisfaction” with their options because of a lack of safety or efficacy.

Kesimpta, though, boasts an “uncompromised balance” of those attributes, Bultó said, calling the therapy “arguably one of the safest, if not the safest,” disease-modifying drug out there.

“Traditionally, there’s always a tradeoff to be made—efficacy or safety,” he said. But Kesimpta “hits the mark on both.”

Novartis padded that efficacy case late in May, revealing at the virtual Congress of the European Academy of Neurology that 47% of Kesimpta patients in a late-stage trial showed no evidence of disease within a year, while just 24% of those taking Aubagio could say the same.

The Swiss drugmaker isn’t planning to skate by on the drug’s safety and efficacy profile alone, though. It’s also wielding a convenience advantage: It’s a once-monthly injection that patients can give themselves at home, while Aubagio is a daily pill and Ocrevus is an IV infusion.

That’s a leg up that, especially during the COVID-19 pandemic, Novartis believes “is pretty important,” Bultó noted.

While rolling out a new product during a global health crisis is “uncharted territory,” the “concern patients have of going to the hospital or infusion centers is really relevant, and we can tackle that during these uncertain times we are all living in,” he said.

At-home administration isn’t just an advantage for patients, though. It also means that there are no additional costs related to infusion, including the “typical markup that infusion centers add,” Bultó said. “So we think this is a very strong value proposition for payers as well.”

RELATED: FDA hits Novartis with unexpected 3-month delay on MS drug ofatumumab

The FDA’s positive Kesimpta verdict follows an unexpected three-month delay from the agency, announced in early June. Novartis at the time stayed tight-lipped on the reasoning behind the setback, saying only that it would “continue to work with the FDA” to wrap up the review.