Novartis is nearing the finish line in a four-year race to repurpose its chronic lymphocytic leukemia drug Arzerra (ofatumumab) in multiple sclerosis, and new data released Friday could help it get there.
The drug—a once-monthly injection that patients can give themselves at home—reduced relapse rates by 50.5% in one phase 3 trial and 58.5% in another when compared with Sanofi’s Aubagio, a daily pill, the company said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Arzerra also reduced the risk of MS patients’ disabilities progressing by 34.4% over three months and 32.5% over six months. And it was better at suppressing brain lesions and inflammation than Aubagio was, Novartis said.
The company will release details about lesion reduction in an upcoming publication, Danny Bar-Zohar, global head of neuroscience development for Novartis Pharmaceuticals, said in an interview with FiercePharma. But an earlier study comparing the drug to placebo showed a 90% or higher reduction in the number of new lesions, and the results seen in the studies presented at ECTRIMS are expected to be “extremely similar,” he said.
“Patients on ofatumumab had a relapse rate of 0.1. That’s a single relapse every 10 years, which is quite unheard of,” Bar-Zohar said. “When we looked at the inflammatory rate in the brain with MRI, ofatumumab showed highly significant, almost complete suppression of disease activity as compared to Aubagio.”
Novartis plans to file for regulatory approval of the product by the end of the year. Arzerra will carry a different brand name if it’s approved in MS.
Novartis isn’t the only company that’s trying to best Sanofi in relapsing MS. At ECTRIMS on Wednesday, Johnson & Johnson unveiled data on its S1P1 immunomodulator candidate, ponesimod, which was also tested in a head-to-head trial against Aubagio. J&J’s drug reduced the relapse rate by 31% and the number of lesions by 56% as compared with Aubagio.
Ponesimod, which J&J got as part of its $30 billion acquisition of Actelion in 2017, was also better at reducing fatigue than Aubagio was, J&J said. The data will be used to back regulatory filings planned in the U.S. and Europe.
Novartis’ drug works by binding to surface molecule CD20 on B cells and eliminating them. Other therapies target CD20-expressing B cells, including Roche’s blockbuster Ocrevus, which is an infusion. But Bar-Zohar sees some advantages in Novartis’ approach. Ofatumumab binds to its target in such a way that allows for a relatively low dose of the drug to be used, so if patients need to go off the drug—say to treat an infection—their B cell population recovers quickly, he said: “The recovery takes about half the time as it does with the infused drugs.”
It won’t be Novartis’ first experience marketing a new drug in the crowded MS market. The company is already facing that challenge with Mayzent, an oral treatment for secondary progressive multiple sclerosis (SPMS) that won FDA approval in March. It’s a form of MS that’s tough for physicians to recognize, making the marketing task that much more difficult for Novartis.
Earlier at ECTRIMS, Novartis released new data on Mayzent that could provide a major boost to its marketing efforts. The company unveiled results from a post hoc analysis showing that Mayzent delayed the need for a wheelchair by four years as compared with placebo.
Novartis had already shown that Mayzent reduced the risk of disability worsening by up to 20%, but the wheelchair data offers “a really nice addition to the overall reduction of disability progression in these SPMS patients,” Norman Putzki, M.D., Novartis Pharmaceuticals' global program head for neuroscience, said in an interview with FiercePharma.
If Novartis is able to add Arzerra to its MS portfolio, it will be a happy ending to a story of an acquired drug that never quite lived up to expectations. Novartis picked up the product in 2015, when it acquired GlaxoSmithKline’s oncology portfolio. It is approved to treat chronic lymphocytic leukemia but has struggled to compete with Johnson & Johnson and AbbVie’s powerhouse Imbruvica.
As for the competition in MS, both Aubagio and ponesimod are oral drugs, while Novartis’ product is an injection, but Bar-Zohar predicts patients won’t focus so much on the differences in how the medicines are administered. “Whether a once-daily pill is better than a once-monthly injection at home, I don’t know,” Bar-Zohar said. “But what I do know is when you have high efficacy at your fingertips, and you don’t have to spend a half day at an infusion center, that’s very important to patients.”