Novartis is hoping for approvals for its new multiple sclerosis therapy siponimod in the US and Europe next year after filing the drug to regulators.
Siponimod (BAF312) – which is a follow-up to Novartis’ established MS therapy Gilenya (fingolimod) – is the first and so far only drug to have demonstrated it can delay the progression of secondary progressive MS (SPMS) in clinical trials, according to the drugmaker.
SPMS is a tough-to-treat variant of the degenerative condition, and while it is less common than relapsing-remitting MS, which accounts for 80% of all patients, but is much more debilitating and causes steady, irreversible worsening of disability as well as declines in cognitive ability. Around a quarter of patients with RRMS go onto develop SPMS within 10 years of their initial diagnosis.
There is an urgent need for effective treatments for SPMS, and that has analysts predicting blockbuster sales for siponimod if it clears regulatory review.
In the EXPAND study presented at this year’s American Academy of Neurology (AAN) conference, siponimod showed a 14-20% reduced risk of disability progression in SPMS compared to placebo at three-months, with the difference expanding to 29-33% at the six-month timepoint. Siponimod also seemed to have a meaningful benefit on patients’ cognitive processing speed in the study.
Novartis wants to get the new orally-active drug to patients as quickly as possible so is using a priority review voucher it earned for an earlier product approval to shorten the FDA’s review time – setting up a possible approval there next March. In Europe, a verdict is expected sometime before the end of 2019.
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