Novartis Provides Additional Phase III Data for MS Drug Siponimod: Prepares to Seek FDA Approval

One month after publishing data that showed multiple sclerosis drug siponimod generated significant improvements in patients, including a 21 percent decrease in the risk of disease progression, Novartis released new information that showed the drug consistently reduced the risk of confirmed disability progression in secondary progressive multiple sclerosis (SPMS) patients.

In its latest report from the Phase III EXPAND trial Novartis said new post-hoc analyses showed that siponimod-dosed patients gained a significant benefit in cognitive processing speed. That speed is the key cognitive function impacted by multiple sclerosis, the Swiss-based company said this morning.

Danny Bar-Zohar, Novartis global head of neuroscience, said a decline in the ability to rapidly process information affects more than half of MS patients. That decline is more severe in secondary progressive MS than relapsing-remitting MS.

"These data show that siponimod could have a meaningful impact on these patients' daily lives. Furthermore, the advanced models used in the new analyses help us to better understand the relationship between relapses and disability and the effect of siponimod on these parameters. We are encouraged by these latest findings, which further solidify the clinical evidence for siponimod as a potential new, much needed treatment option for SPMS," Bar-Zohar said in a statement.  

Last month Novartis released the Phase III results that not only showed the aforementioned reduction of disease progression, but data also demonstrated that siponimod, a selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, resulted in a 23 percent reduction of brain volume loss, limited T2 lesion volume from increasing by a mean of about 80 percent, cut the annual relapse rate by 55 percent and showed reduced disease progression to about 26 percent at six months.

Now the latest analysis shows that treatment with siponimod sustained disability progression at three months that ranged from 14 to 20 percent for non-relapsing patients. At six months the result was even greater. Those numbers were 29 to 33 percent, Novartis said.

There are approximately 2.3 million people affected with multiple sclerosis worldwide. SPMS is characterized by gradual worsening of neurological function over time, which leads to a progressive accumulation of disability that is largely disassociated from relapses. SPMS can severely affect patients' abilities to carry out everyday activities.

Novartis is planning to seek regulatory approval from the U.S. Food and Drug Administration during the first half of this year. The company said it will seek approval in the European Union later in 2018. Approval would certainly bolster Novartis’ MS pipeline. Currently, the company has the blockbuster treatment Gilenya in its arsenal. Last year the drug brought in about $3 billion for the company. However, within the next two years, Gilenya will be challenged in the United States by generic drugs. In addition to Gilenya Novartis also markets Extravia as a treatment for relapsing forms of the disease.

Bruce Cree, the principal investigator of siponimod, said the drug’s beneficial effect on preventing disability progression demonstrated that patients with SPMS could benefit from the medication. In a statement, Cree called the news exciting due to the fact that many people "diagnosed with relapsing-remitting MS, the most common form of the disease, will ultimately transition to SPMS, where without effective new therapies, they experience gradual worsening of disability despite infrequent relapses.

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