FDA Approves Drug for Secondary Progressive MS

More than 2.3 million people live with multiple sclerosis, or MS, worldwide.

Now, for the first time in more than a decade, the U.S. Food and Drug Administration (FDA) has approved a new medication for secondary progressive MS – a hard-to-treat form of the disease that impacts people who have lived with MS for a long period of time.

Cleveland Clinic’s Robert Fox, M.D., said trials have shown the drug, siponimod, which is taken in pill form, to be effective in slowing the progression of this form of MS.

“The patients treated with siponimod had a slower progression of disability than the patients treated with the placebo,” he said. “What the trial also found, is that the patients who had active inflammation at the beginning of the trial, responded even better to siponimod compared to placebo.”

Dr. Fox said about 85 percent of MS cases begin with the relapsing-remitting stage, which involves episodes of numbness, weakness, or blurry vision.

When doctors can intervene quickly, and get the disease under control, most patients do very well over the long period.

However, over time, gradual worsening in function, which is known as secondary progressive MS impacts a person’s ability to walk, use their arms, and their cognitive function.

Dr. Fox said it’s key to keep in mind that this new drug is only approved for secondary progressive MS patients who continue to have episodes of numbness, weakness or blurry vision.

And the medicine is only able to slow the progression of MS, not eliminate or cure it.

“An important aspect of this drug is that it’s only partially effective,” he said. “It only slowed the progression of disability by about 21 percent; so, it’s not a cure for secondary progressive MS, but we do think that it is likely to be a helpful addition for many patients.”

Dr. Fox said certain side effects, such as a slowing heart rate was shown during the trials.  Therefore, patients with a history of heart rhythm difficulties or heart attack need to talk to their doctor about the safety risks of this medication.

There is also an increased risk to the liver, so liver-monitoring is important over the course of taking this therapy.

He said one thing that experts don’t yet know, is how well the drug can work for people who have had secondary progressive MS for a long period of time.