Novartis’ newly approved multiple sclerosis therapy Mayzent has already shown an ability to cut disability progression and forestall brain shrinkage in patients with the secondary progressive form of the disease (SPMS). Now, it has more data to back its case.
Additional analysis of the 1,651-patient phase 3 Expand study—which helped Novartis win an FDA nod in March—found Mayzent also had a meaningful benefit on cognitive processing speed, which measures how a person can understand and respond to information they receive.
“The significant effects on cognitive impairment presented at AAN continue to build on the evidence that Mayzent can delay disability progression and positively impact patients’ lives,” Novartis’ head of neuroscience development, Danny Bar-Zohar, said in a statement.
Mayzent beat placebo on a standard test regardless of the stage of SPMS, Novartis unveiled at the American Academy of Neurology annual meeting in Philadelphia.
Patients treated earlier and who had less cognitive impairment coming into the study benefited most from Mayzent, with a much higher proportion enjoying improvement. And those who started the trial with low test scores also experienced slower deterioration, Novartis said.
Previously, Mayzent showed it could slow brain volume loss in SPMS patients by more than 20%. Brain shrinkage is linked to loss of cognitive function and disability progression.
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Changes in cognitive processing speed are often the first sign of a decline in cognitive functioning in MS, because it affects how people perform simple daily tasks such as remembering information or conversing. Cognitive impairment is also a leading cause of occupational disability among MS patients, Novartis said.
Despite the processing speed benefit, though, Mayzent didn’t move the needle in a test assessing memory.
Novartis has high hopes for Mayzent as a follow-up to its top-selling MS pill Gilenya; after all, it’s the first FDA-approved treatment for SPMS in more than 15 years and, according to Novartis, the only one that’s been studied in typical SPMS.
About 50% to 80% of patients with relapsing-remitting MS go on to develop secondary progressive disease, and Mayzent could take “all-comers” who’ve progressed, not just those previously treated with Gilenya, Novartis pharma chief Paul Hudson said on the company’s first-quarter earnings call in April. Evaluate Pharma previously pegged the drug’s 2024 sales at $1.3 billion.
To achieve that goal, Novartis has started educating doctors and helping them identify SPMS with an algorithm test, Bar-Zohar previously told FiercePharma.