- The Food and Drug Administration on Thursday approved Kesimpta, formerly known as ofatumumab, a drug developed by Novartis for patients with the relapsing form of multiple sclerosis, the most common form of the disease.
- The agency cleared Kesimpta a month ahead of its scheduled decision date, based on two Phase 3 studies published this month in the New England Journal of Medicine showing its ability to reduce various symptoms of MS progression. The drug will cost $83,000 per year, before discounts and rebates to insurers.
- Kesimpta is the first injectable MS drug that patients can self-administer at home, an advantage the Swiss drugmaker is relying on to leap to the forefront of almost 20 rival treatments — chiefly Roche's Ocrevus, which works similarly to Kesimpta but is infused twice yearly at a doctor's office.
The treatment landscape for multiple sclerosis has changed significantly over the past decade. With the approval of Kesimpta, that shift could accelerate.
Since 2010, close to 10 new treatments have emerged that are meant to slow the progression of the disease, which afflicts nearly 1 million Americans. The entry of those drugs — among them Biogen's top-seller Tecfidera, and more recently, Roche's Ocrevus — has been part of a shift away from older medicines, like interferons, and towards pills and monoclonal antibodies.
Despite the increasingly crowded market — there are now 15 so-called disease-modifying therapies available — there's still a "substantial unmet need" for new drugs, said Victor Bulto, head of Novartis's U.S. Pharmaceuticals division.
Nearly half of MS patients aren't happy with their treatment, and a third of them switch drugs each year, he says. "The implication is that patients continue to relapse," Bulto said, referring to the sudden flare-up or worsening of symptoms that characterize the disease.
The fast rise of Ocrevus in a competitive market has been a testament to that theory. Since 2017, it has become the first and only drug approved both for the common "relapsing" form of MS and the more rare, and severe "primary progressive" version. It generated $3.79 billion last year alone, and could soon become the top-selling MS drug in the world, unseating Tecfidera, which could soon face multiple generic challengers.
Novartis is aiming for a similar trajectory with Kesimpta, a different, low-dose formulation of the old leukemia drug Arzerra. Like Ocrevus, Kesimpta targets a protein called CD20 that's present on the surface of the immune system's B cells — a method thus far that's proven very effective at delaying MS symptoms. In two Phase 3 trials, for instance, Kesimpta patients had an annual relapse rate of 0.1, which equates to one every 10 years. Roche has seen similar results with Ocrevus, but the drugs haven't been compared head-to-head, and Bulto indicated that Novartis doesn't plan to run such a test.
The big difference between the two drugs is how they're administered. Patients can get Kesimpta delivered to their homes, and administer it via an injection just under the skin once a month. They have to drive to infusion centers for Ocrevus twice a year. The safety profile cited in the FDA's prescribing information is also superior to Ocrevus, in that it doesn't have a warning citing the risk of malignancies.
"That's a value proposition that's very relevant during COVID-19," Bulto said, referring to how the coronavirus pandemic has made patients more hesitant to seek out care.
Novartis is relying on that profile to sway patients and doctors. But it's also priced Kesimpta above its chief rival. Ocrevus costs $65,000 per patient per year, well below many other MS drugs and $18,000 below the cost Kesimpta comes to market with.
Novartis spokesperson Eric Althoff countered, however, that analyses the company has conducted suggest that the total cost of infused MS therapies like Ocrevus can be 55% higher than their list price, because of the associated costs of a drug administered at a clinic.
"Relative to this comparison, Kesimpta is priced at a discount," wrote Cowen analyst Steve Scala, who expects the drug to generate $1.5 billion in global sales in 2025.
Kesimpta was originally developed by GlaxoSmithKline and Denmark-based Genmab. Novartis bought GSK's rights, however, several years ago.