Last September, Novartis turned up the heat in multiple sclerosis (MS) with data showing its repurposed anti-CD20 leukemia drug Arzerra cut relapse rates by more than 50% in two trials over Sanofi’s Aubagio.
Now, Novartis is expecting an FDA verdict on Arzerra (ofatumumab) in MS next month, and it’s rolling out more data in support of its effort to steal some market share from Sanofi.
Novartis announced that in phase 2 and 3 trials, 47% of patients taking ofatumumab showed no evidence of disease—as measured by relapses, progression and brain lesions—within the first year, versus just 24% of those on Aubagio. After two years, nearly 90% of trial participants on the Novartis drug were clear of disease, compared with 48% of Aubagio patients. The company released the data at the virtual Congress of the European Academy of Neurology.
Novartis picked up Arzerra, approved to treat chronic lymphocytic leukemia (CLL), as part of its acquisition of GlaxoSmithKline’s cancer portfolio in 2015. The product, which will carry a different brand name if it’s approved for MS, has never quite managed to compete successfully in CLL against Johnson & Johnson and AbbVie’s Imbruvica.
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The newly released data could very well turn ofatumumab into a major player in MS, though, particularly because the drug also boasts a convenience benefit. It’s a once-a-month injection that patients can give themselves, while Aubagio is a daily pill. The two drugs were comparable in terms of safety during the trials, Novartis said.
Sanofi won’t be the only competitor Novartis will have to worry about in MS. On March 20, Johnson & Johnson’s Janssen unit filed for approval of its S1P1 immunomodulator ponesimod, which it acquired in its $30 billion buyout of Actelion in 2017. Last fall, J&J presented data showing that it lowered the relapse rate in MS by 31% over Aubagio in addition to reducing fatigue.
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Roche’s Ocrevus, an IV infusion that also targets CD20-expressing B cells, is a noteworthy competitor, too. But ofatumumab binds to its target in such a way as to allow for a relatively low dose to be used—potentially offering another benefit aside from the fact that patients can inject it themselves—said Danny Bar-Zohar, Novartis’ then global head of neuroscience development, in an interview with FiercePharma last fall.
If a patient needs to temporarily stop taking ofatumumab to treat an infection, say, his or her B cells would recover in “about half the time as it does with the infused drugs,” Bar-Zohar said.
No doubt Wall Street’s expectations for ofatumumab in MS will be high if the FDA gives it the thumbs-up next month. Last November, four out of five physicians who treat MS told analysts at SVB Leerink they were excited to see the drug come to market, noting that it has the potential to offer “'Ocrevus-like' efficacy, with the convenience of self-administration,” SVB Leerink said in a report.
What’s more, the physicians predicted “that over time 50% or more of their practices may be switched to ofatumumab based on its dosing schedule.”
Editor's note: This story has been updated with additional details from Novartis.