Novartis is looking to grow its new multiple sclerosis drug Mayzent in a crowded field, and, with Gilenya generics threatening, the newer MS medicine may need to carry even more weight. It just racked up some new data that could help.
New long-term data for Mayzent released Tuesday showed early treatment helped stave off disease progression in patients with secondary progressive MS (SPMS). The five-year open-label study extension, dubbed Expand, tracked the oral MS drug in two groups of SPMS patients—those who had been on the drug at the start of the trial extension and those who had switched from placebo.
Those who'd already been using Mayzent were “significantly less likely” to experience confirmed disability progression, the drugmaker said. The Mayzent group also saw a 52% reduction in annualized relapse rate compared with the placebo switch patients.
The risk of worsening of cognitive impairment at the six-month mark was 23% lower for patients who had been taking Mayzent longer. And the benefits for early treatment initiation were sustained for up to five years, Novartis said.
The data were published in the journal Neurology after the American Academy of Neurology’s meeting had to cancel due to the COVID-19 pandemic.
Novartis is looking to grow market share and sales for its 2019 multiple sclerosis launch, which faces not only the usual challenges for new rollouts but the difficulties in diagnosing SPMS. Doctors aren't as familiar with the secondary progressive form of the disease, and Novartis has been working to spread the word.
In many cases, patients and doctors aren’t sure whether a patient has progressed to SPMS. It’s often a “retrospective diagnosis,” Danny Bar-Zohar, Novartis’ global head of neuroscience development, told FiercePharma last year. About 1 in 4 patients with relapsing-remitting MS progress to SPMS within 10 years, according to the company.
Mayzent generated $26 million last year, but the company says the drug could eventually become a blockbuster as diagnosis rates improve.
Tuesday, Novartis also shared a post hoc analysis of the phase 3 Expand trial showing potential benefits in stalling disability progression, fending off cognitive decline and promoting central nervous system repair.
Novartis is looking to grow Mayzent as its older Gilenya faces patent challenges from numerous companies. The older drug generated $3.2 billion last year, and in December the FDA approved three potential copycats. Those generics can’t launch until a patent dispute with Novartis is resolved; analysts have said that might happen in 2020.
Meanwhile, the MS field has grown increasingly competitive in recent years with launches for several new medicines, including Merck KGaA’s Mavenclad and Biogen’s Vumerity.