Back in June, the FDA extended its deadline for decision for Novartis’ multiple sclerosis prospect ofatumumab by three months. But it turns out that the agency was not needed for so long.
U.S. regulators on Thursday removed the drug, which will go by the name Kesimpta, into relapsing forms of MS, including relapsing-remitting disease and secondary progressive disease. It will carry a list price of $ 83,000, making it “one of the cheapest brands (disease-modifying therapies),” a company spokeswoman said in an email, adding that the drug is competitively priced to reflect its unique value and provide broad access. ”
Speaking of competition, Kesimpta will have a lot. The drug, which targets CD20-expressing B cells – and is already approved as Arzerra in leukemia – is linked to 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 launch of Bristol Myers Squibb that is part of an S1P modulator group that also includes Novartis’ own Mayzent and Gilenya.
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But Novartis does not worry. “Despite this being a crowded space, we believe there is still a major unmet need,” said Victor Bultó, the US president of Novartis, ahead of the green light. According to Novartis findings, about half of patients “signal in principle dissatisfaction” with their options due to a lack of safety or efficacy.
Kesimpta, though, has an “uncompromised balance” of those attributes, Bultó said, calling the therapy “probably one of the safest, if not the safest,” disease-modifying drugs out there.
“Traditionally, there has always been a change – efficiency as well as safety,” he said. But Kesimpta “strikes the mark on both.”
Novartis filed that efficacy case in late May, revealing at the European Academy of Neurology’s virtual congress that 47% of Kesimpta patients in a trial in the late phase within a year showed no evidence of disease, while just 24% of those who take Aubagio say the same.
However, the Swiss drugmaker does not intend to argue about the safety and efficacy profile of the drug. It also has a convenience advantage: It is a once-a-month injection that patients can give themselves at home, while Aubagio is a daily pill and Ocrevus is an IV infusion.
That’s a foot up that, especially during the COVID-19 pandemic, Novartis finds that “pretty important,” Bultó notes.
While rolling out a new product during a global health crisis is “uncharted territory”, the “care that patients have to go to the hospital or infusion center is really relevant, and we can address that in these uncertain times we all live,” ” he said.
However, home management is not only a benefit for patients. It also means there are no additional costs related to infusion, including the “typical markup that infusion centers add,” Bultó said. “That we think this is also a very strong value proposition for payers.”
RELATED: FDA hits Novartis with unexpected 3-month delay on MS drug ofatumumab
The FDA’s positive Kesimpta ruling follows an unexpected three-month delay by the agency, announced in early June. Novartis at the time remained tight-lipped about the reasoning behind the commitment, saying only that it would “continue to work with the FDA” to pick up the review.
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