New medicine for multiple sclerosis or MS has been approved by the 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. Is this medication a good option for people with MS? Let’s go through everything to know about this new FDA-approved medicine for MS.
Intro to Multiple Sclerosis.
Multiple sclerosis (MS) is an autoimmune disease. With these conditions, your immune system mistakenly attacks healthy cells. In people with MS, the immune system attacks cells in the myelin, the protective sheath that surrounds nerves in the brain and spinal cord.
Damage to the myelin sheath interrupts nerve signals from your brain to other parts of your body. The damage can lead to symptoms affecting your brain, spinal cord, and eyes.
There are four types of multiple sclerosis:
- Clinically isolated syndrome (CIS): When someone has the first episode of MS symptoms, healthcare providers often categorize it as CIS. Not everyone who has CIS goes on to develop multiple sclerosis.
- Relapsing-remitting MS (RRMS): This is the most common form of multiple sclerosis. People with RRMS have flare-ups — also called relapse or exacerbation — of new or worsening symptoms. Periods of remission follow (when symptoms stabilize or go away).
- Primary progressive MS (PPMS): People diagnosed with PPMS have symptoms that slowly and gradually worsen without any periods of relapse or remission.
- Secondary progressive MS (SPMS): In many cases, people originally diagnosed with RRMS eventually progress to SPMS. With secondary progressive multiple sclerosis, you continue to accumulate nerve damage. Your symptoms progressively worsen. While you may still experience some relapses or flares (when symptoms increase), you no longer have periods of remission afterward (when symptoms stabilize or go away).
What causes multiple sclerosis (MS)?
Experts still don’t know for sure what causes multiple sclerosis. Research is ongoing to help identify what causes the disease. Factors that may trigger MS include:
- Exposure to certain viruses or bacteria: Some research suggests that being exposed to certain infections (such as Epstein-Barr virus) can trigger MS later in life.
- Where you live: Your environment may play a role in your risk for developing MS. Certain parts of the world have significantly higher rates of the disease than others. Areas farther from the equator have higher rates of MS. That may be because these regions receive less intense sun. People who get less sun have lower levels of vitamin D, a risk factor for developing MS.
- How your immune system functions: Multiple sclerosis is an autoimmune disease. Researchers are working to figure out what causes some people’s immune cells to mistakenly attack healthy cells.
- Gene mutations: Having a family member with MS does increase your risk of the disease. But it’s still unclear exactly how and which genes play a role in triggering multiple sclerosis.
What are the symptoms of multiple sclerosis?
Vision problems — such as optic neuritis (blurriness and pain in one eye) — are often one of the first signs of multiple sclerosis. Other common symptoms include:
- Changes in gait.
- Fatigue.
- Loss of balance or coordination.
- Muscle spasms.
- Muscle weakness.
- Tingling or numbness, especially in your legs or arms.
What you should know about the new FDA approved medicine for MS: Ponvory.
PONVORY™ (Ponesimod) is an oral disease-modifying therapy approved for the treatment of adult patients with relapsing forms of multiple sclerosis (MS).
In 2017, Actelion Pharmaceuticals, a member of Janssen Pharmaceutical Companies of Johnson & Johnson’s (JNJ), reached a revenue-sharing agreement with Idorsia Pharmaceuticals. The agreement allows Idorsia to receive quarterly payments of 8% of the net sales of Ponesimod products per quarter.
PONVORY is available as biconvex, round, film-coated tablets in 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg, 10mg and 20mg dosage strengths for oral administration.
Mode of Action.
PONVORY is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that binds with high affinity to S1P1.
Ponesimod traps lymphocytes in the lymph nodes and keeps them out of the blood. The mode by which Ponesimod executes its therapeutic action in MS is not known, but it may help reduce migration of lymphocytes into the CNS.
In March 2020, Janssen, the pharmaceutical subsidiary of Johnson & Johnson, submitted a new drug application (NDA) for ponesimod to the US Food and Drug Administration (FDA).
In March 2021, the US FDA approved PONVORY (ponesimod) as a treatment for MS to help reduce relapses and brain lesions in adult patients.
The FDA approval also includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
In March 2020, Janssen submitted a marketing authorization application (MAA) for ponesimod to the European Medicines Agency (EMA).
In March 2021, the company received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for ponesimod to treat adult patients with relapsing MS with active disease defined by clinical or imaging features.
Possible side effects of PONVORY.
1. Breathing problems.
Some people who take PONVORY™ have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
2. Liver problems.
PONVORY™ may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking PONVORY™. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
- unexplained nausea
- vomiting
- stomach (abdominal) pain
- tiredness
- loss of appetite
- yellowing of the whites of your eyes or skin
- dark urine
3. Increased blood pressure.
Your healthcare provider should check your blood pressure during treatment.
4. Types of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma.
Certain types of skin cancer have happened with drugs in the same class. Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with PONVORY™. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
5. A problem with your vision called macular edema.
Tell your healthcare provider about any changes in your vision. Your healthcare provider should test your vision before you start taking the new FDA-approved medicine PONVORY™ for MS and any time you notice vision changes during treatment with PONVORY™. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.
