FDA Has Approved a New MS Medication: What to Know

A new drug for MS has just been approved by the FDA. Brothers91/Getty Images

A new treatment has been approved for people with multiple sclerosis. In clinical trials, the medication demonstrated that it reduced relapses by 30.5 percent…

A new drug for MS has just been approved by the FDA. Brothers91/Getty Images
  • A new treatment has been approved for people with multiple sclerosis.
  • In clinical trials, the medication demonstrated that it reduced relapses by 30.5 percent compared with other MS medications.
  • Ponvory is taken once a day. Other MS medications are taken multiple times per day.

A new medication for multiple sclerosis (MS) has been approved by the Food and Drug Administration (FDA).

The new medication, Ponvory, is a once-daily oral treatment. It's been shown to reduce annualized relapse rates and new brain lesions in people with MS.

This approval is based on a 2-year phase 3 clinical trial. In the trial, the medication demonstrated that it reduced relapses by 30.5 percent compared with other medications.

Seventy-one percent of trial participants who received Ponvory had no confirmed relapses.

Ponvory also reduced the number of new gadolinium-enhancing TI lesions and the number of new or enlarging T2 lesions by 59 percent and 56 percent, respectively.

Is this medication a good option for people with MS? We spoke with experts to get their insight.

What is multiple sclerosis?

MS is a condition that affects the brain and central nervous system. With MS, the immune system attacks the protective covering over the nerve fibers, which can cause miscommunication between the brain and body. 

People with MS can experience:

  • numbness or weakness in one or more limbs
  • electric shock sensations with certain neck movements
  • tremors or lack of coordination
  • partial or complete loss of vision
  • prolonged double vision
  • blurry vision
  • slurred speech
  • fatigue
  • dizziness
  • tingling or pain in the body
  • problems with sexual, bowel, and bladder function

How do MS medications work?

While there's no current cure for MS, a variety of medications can help speed up the recovery from MS attacks.

These medications work by curbing the immune system so that it stops attacking the coating around the nerves. Medications come in the form of infusions, injections, or, like in the case of Ponvory, pills.

“There are more than 22 drugs for MS right now,” said Dr. Karen Blitz-Shabbir, neurologist and director of the MS program at New York-Presbyterian Methodist Hospital.

“Medicine is still an art. In MS treatment, it has to be very patient-centric because everyone has a very different symptom and disease with MS. It's nice to have options. Every medication has a place,” she said.

What makes this medication different?

Ponvory is categorized as a S1P medication, or a sphingosine-1-phosphate receptor.

It's used as an immunomodulator. This means it locks onto receptors in the lymph nodes and can prevent certain immune cells from being released to the central nervous system.

It essentially slows or reduces the attacks on the central nervous system.

“There are three other S1P inhibitors,” Blitz-Shabbir said. “Each one has a slightly different side effect profile. Some require cardiac monitoring, while others don't. Some reverse effects on white cells a little quicker. That's why this is an art.”

Ponvory is taken once a day, whereas other MS medications are taken multiple times per day. Additionally, it's taken orally. Other MS treatments are often injections or infusions.

In the clinical trials for Ponvory, which included 1,133 participants, the safety and tolerability of the 20-milligram dose was reported to be higher than competitive medications.

“This is similar to a lot of other options that we have on the market already,” said Dr. Asaff Harel, a neurologist at Lenox Hill Hospital in New York.

“I think that the one thing that this has is that it has a bit of a shorter half-life [compared to other MS treatments], which means it has a faster elimination [of relapses],” he said.

“In my view,” Harel added, “it's a double-edged sword. If there is an interruption in taking the medication, that can be a concern. On the flip side, if there is a concern with this medication, like an infection, it can be reversed very quickly.”

“I have been doing this a long time,” Blitz-Shabbir said. “When the first shot came out it was by lottery system. We've come a long way. It's a pretty straightforward concept. We have many choices. We assess the patient, assess the disease, and make a decision. There is a place for a lot of therapies. I think this one will be useful.”

Each case of MS is different. Every person with MS has their own set of symptoms and experiences with the disease.

It’s never a bad thing to have a variety of efficient options to choose from when diagnosing and treating MS.

“This is pretty clearly an effective oral medication,” Harel said. “I would say it is for someone who likes the idea of taking one pill a day as opposed to multiple pills per day, or having injections or infusions. This provides another option.”