FDA Approves Ponvory, a New Medication for Relapsing Multiple Sclerosis

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FDA Approves Ponvory, a New Medication for Relapsing Multiple Sclerosis

Christina Aungst, PharmDChristina Aungst, PharmD

March 31, 2021, 3:35PM (PT)

Key takeaways:

  • Ponvory is a once-daily oral tablet that was recently approved by the FDA to treat relapsing multiple sclerosis (MS).
  • Ponvory’s most common side effect is a higher risk of infections, especially upper respiratory infections. 
  • In studies, Ponvory was better at preventing multiple sclerosis relapses than Aubagio, a current first-choice treatment for relapsing MS.

Multiple sclerosis (MS) is an autoimmune disorder that causes your immune system to attack your nerves. It currently impacts almost 1 million adults across the country. Medication regimens used to treat the condition vary widely, are often unique and tailored to each person, and can include injection, infusion, and oral options. 

In March 2021, the FDA approved a new oral medication called Ponvory (ponesimod) that will give healthcare providers another option for treating MS. Study results are promising, suggesting that it may work better than some of the other options currently on the market.

Below, we’ll cover what Ponvory is, its possible side effects, and when you can expect it to be available. But first, let’s talk about the form of MS it will treat — relapsing MS.

What is relapsing MS?

Relapsing MS — also called relapsing-remitting MS — is the most common type of MS. People with this condition will have periods where their symptoms are well-controlled or even completely absent (called remission) followed by periods where their symptoms are not controlled (called a relapse or flare-up). 

This pattern of remissions and relapses will repeat throughout the person’s life, and every relapse has the potential to cause permanent nerve damage. Many MS medications, including Ponvory, aim to prevent as many relapses as possible.

What is Ponvory?

Ponvory is a once-daily oral tablet that will help people with relapsing MS. Some medications used to treat MS are injectable, so an oral option may be preferred by some people. Ponvory belongs to a group of medications known as sphingosine-1-phosphate (S1P) receptor modulators. 

Next, we’ll discuss how it works to prevent MS flare-ups.

How does Ponvory work for preventing relapses?

Ponvory attaches to the S1P receptors in your body and tells them to stop sending white blood cells — a major part of your immune system — to your nervous system. Less white blood cells around your nerves means less nerve damage. One unique thing about Ponvory is that it only attaches to certain S1P receptors. This should help it have milder side effects than other, less selective medications in this class.

How will I take Ponvory?

Ponvory should be taken by mouth once a day around the same time every day. You can take it with or without food, but it must be swallowed whole. If you have trouble swallowing pills, let your provider know, as this may not be the best option for you. 

You will start with a very low dose of Ponvory using a starter pack, which gradually raises the dose over the course of 2 weeks until you are taking 20 mg once a day.Don’t miss out on savings!Get the best ways to save on your prescriptions delivered to your inbox. By signing up, I agree to GoodRx’s terms of service and privacy policy, and to receive marketing messages from GoodRx.

What are the known side effects of Ponvory?

As with many medications used for autoimmune diseases, the biggest risk and most common side effect with Ponvory is a higher risk of infections. While the most common type of infection experienced while taking this medication is upper respiratory infections, it is also possible to get sick with more serious illnesses like meningitis and pneumonia.

Ponvory can temporarily lower your heart rate when you first start taking it, especially if you take too high of a dose too soon. This is why your dose will be raised gradually in the beginning. You may have to have an electrocardiogram (ECG or EKG) done before taking Ponvory to make sure your heart is healthy. If you have certain heart problems, this may not be the best medication for you.

Other common side effects that might happen while taking Ponvory include:

  • Changes to liver blood tests
  • High blood pressure
  • Urinary tract infections (UTIs)
  • Trouble breathing
  • Dizziness

Does it interact with other medications?

Taking other medications that can weaken your immune system, including corticosteroids and Lemtrada, raises your risk of serious infections, so it’s typically best to avoid this combination whenever possible. 

Certain heart medications also interact with Ponvory and raise your risk of a heart rhythm problem called long QT syndrome. While rare, this issue can be life-threatening. Be sure to ask your pharmacist to check for drug interactions when filling your Ponvory prescription.

Your provider will also need to be cautious while starting you on Ponvory if you are taking a beta blocker for a condition like high blood pressure. Beta blockers work by lowering your heart rate, so it is possible that it could get too low as you are working your way up to the full dose of Ponvory. 

Lastly, live vaccines like the measles-mumps-rubella (MMR) vaccine and Flumist nasal flu vaccine should be avoided while you’re taking Ponvory. Experts aren’t sure if these types of vaccines are safe to receive while using medications that can weaken your immune system. 

It’s also important to note that while inactivated vaccines like Shingrix and the injectable flu shot are safe to receive, they may be less effective while taking Ponvory.

How does Ponvory compare to other relapsing MS medications like Aubagio (teriflunomide)?

In April 2020, results from Ponvory’s phase 3 clinical trial — the last stage before a manufacturer can seek FDA approval — were published. Ponvory was compared to Aubagio, a medication considered to be a first choice for treating relapsing forms of MS. People in this study were followed for 2 years to see how many relapses they had during that time.

The results showed that 71% of those taking Ponvory had no relapses during the 2 years compared to 61% of those taking Aubagio. This was considered to be a significant difference, meaning that Ponvory prevented flare-ups better than Aubagio. It was also noted that the amount of side effects experienced was similar regardless of which medication people took.

How much will Ponvory cost?

Until Ponvory is available, we won’t know exactly how much it costs. However, other medications in the S1P receptor modulator class can cost several thousand dollars without insurance, so we’re expecting this medication to also be expensive. Janssen, the manufacturer of Ponvory, does have a financial assistance program to help you afford the cost of the medication, so be sure to check it out.

When will Ponvory be available?

Your provider won’t have to wait too long to prescribe Ponvory. It’s expected to be available during April 2021. Be sure to discuss this medication at your next appointment to see if it’s a possible option for you.

The bottom line

Ponvory is a newly approved medication that will provide another option for treating relapsing multiple sclerosis. Being a once-daily oral tablet makes it more convenient than some injectable alternatives, and studies suggest it works better than Aubagio, a current first choice for this condition. Expect it to be available at the pharmacy in the coming months. 


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