Novartis pads case for new MS blockbuster with disease-progression analysis

Novartis is hoping multiple sclerosis candidate siponimod’s performance in secondary progressive patients can help it secure a blockbuster approval. And now it has more data to put toward that case.

Friday, ahead of the American Academy of Neurology annual meeting, the Swiss drugmaker said the wannabe product had cut the risk of confirmed disability progression in SPMS sufferers both with and without relapses.

The results follow up on previously released data showing that siponimod could drive a significant reduction in the risk of a patient's disability worsening, but use a “more advanced, model-based approach,” Novartis said. That approach set the risk reduction between 14% and 20% compared with placebo at three months for non-relapsing patients. And at six months, that benefit was even greater, checking in between 29% and 33%.

New analyses also showed the drug had a positive effect on cognitive processing speed, which often deteriorates in SPMS patients.

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Study steering committee member Bruce Cree called the findings “very exciting,” noting that many people with relapsing-remitting MS, the most common form of the disease, “will ultimately transition to SPMS.”

“Without effective new therapies, they experience gradual worsening of disability despite infrequent relapses,” he said in a statement.

Right now, that group of patients has a dearth of options, and that has Novartis hopeful it can take siponimod to blockbuster territory. Of the 2.3 million patients worldwide suffering from MS, 85% of those have relapsing-remitting disease, and almost 25% of those patients will go on to develop secondary progressive MS within 10 years of their initial diagnoses. After 30 years, that number climbs to more than 75%, according to Novartis.

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And with Novartis MS treatment Gilenya set to face generic competition in 2019, that new revenue will be welcome. Knockoffs will descend early on the oral med after the pharma giant lost a fight over a 2026 patent at the U.S. Federal Circuit last year.