Dive Brief:
- Novartis AG last week presented new data for its experimental multiple sclerosis drug siponimod, showing the treatment cut the risk of disability progression and improved cognitive processing speed in patients with secondary progressive forms of the debilitating disease.
- Further analyses of the Swiss pharma's EXPAND study demonstrated the risk reduction previously reported for siponimod is largely disassociated from relapses. For non-relapsing patients, treatment with siponimod reduced the risk of disability progression versus placebo by 29% to 33% at six months.
- Novartis plans to submit the drug for European approval later in 2018, while a regulatory application in the U.S. has been initiated, according to the company's April 20 statement.
Dive Insight:
Hot on the heels of data published last month, Novartis' new details provide more information to support the company's submission for approval for siponimod. If OK'd by the FDA, the drug would become the first disease-modifying treatment for secondary progressive multiple sclerosis, a later onset form of the disease.
At three months, siponimod reduced the risk of disability progression by between 14% and 20% specifically in non-relapsing patients.
"Siponimod's beneficial effect on preventing disability progression, independent from its reduction in relapse frequency, demonstrates that patients with secondary progressive MS could benefit from this treatment," said study steering committee member Bruce Cree, an associate professor at the University of California, San Francisco, School of Medicine, in a statement.
Previous released results had shown a risk reduction of 21% at three months and 26% at six months.
Approval could bring new life to Novartis' well-established MS portfolio, which is likely to hit generic competition for Gilenya (fingolimod) over the next few years. The refusal-to-file earlier this year of Celgene Corp.'s ozanimod by the FDA may leave the currently crowded MS market a little less well defended.
Novartis has picked the drug as a future blockbuster, banking on carving out a market niche through the SPMS indication.
Siponimod's impact on cognitive processing speed is also important, as declines in function are usually steeper in SPMS patients than in the more common relapsing form of the disease.