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FDA Approves Oral Ponvory™(Ponesimod) for Relapsing Forms of MS

March 19, 2021

UPDATED 3/30/21
The U.S. Food and Drug Administration has approved Ponvory™ (ponesimod, Janssen Pharmaceutical Companies of Johnson & Johnson) as an oral disease-modifying therapy for adults with relapsing forms of MS.
  • Relapsing forms of MS includes people with clinically isolated syndrome (an initial episode of neurological symptoms), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses and/or new MRI activity.
  • Ponvory is similar to Gilenya® (fingolimod, Novartis International AG), Mayzent® (siponimod, Novartis International AG), and Zeposia® (ozanimod, Bristol Myers Squibb). Ponvory is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system.
  • In a 2-year, phase 3 clinical trial, Ponvory significantly reduced annual relapse rates and reduced MRI-detected disease activity compared with Aubagio® (Teriflunomide, Sanofi Genzyme). There was no significant difference in the proportion of people who experienced disease progression between those taking Ponvory or Aubagio. 
  • UPDATE: A paper describing the clinical trial results was published in JAMA Neurology online on March 29, 2021
  • The most common adverse reactions reported from clinical trials were upper respiratory infection, increases in liver function tests, and high blood pressure. In addition, Ponvory may cause serious side effects (see below under Potential Risks).
  • Starting Ponvory may result in temporary reductions in heart rate. To help reduce this potential side effect, Ponvory is taken in gradually larger doses over 14 days before the standard maintenance dose is achieved. There is no requirement for individuals to be monitored while taking the first dose, except for those with certain pre-existing heart conditions, who should be monitored for 4 hours when receiving their first dose.
  • The company expects Ponvory to be available in April. Additional information on availability, cost, and patient support programs will be provided when they become available.
 “MS is a complex disease, and any individual’s response to MS disease-modifying therapy can vary,” said Dr. Bruce Bebo, Executive Vice President of Research at the National MS Society. “It’s so important that people living with MS have access to effective treatment options. We are pleased that there is a new therapy approved for relapsing MS.”
Download prescribing information (.pdf) The medication guide for patients starts on page 30 of the prescribing information.
Note on starting a disease-modifying therapy during the COVID-19 pandemic: Many experts believe it is safe to start a disease-modifying therapy during the COVID-19 pandemic. Therapies in the same category as Ponvory do not appear to increase the risk of more severe COVID-19 symptoms. ADDITIONAL DETAILS
About Ponvory: Ponvory (pon-vor’-ee) is a selective sphingosine 1-phosphate receptor modulator. It is thought to act by promoting the retention of certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the brain and spinal cord. Similar therapies are approved by the FDA to treat MS: Gilenya (fingolimod), Mayzent (siponimod), and Zeposia (ozanimod).
Potential Benefits: A phase 3 clinical trial involving more than 1,100 people with relapsing MS compared daily oral Ponvory to oral Aubagio. Ponvory was found to significantly reduce annual relapse rates and MRI-detected signs of disease activity more than Aubagio. Ponvory was not shown to slow disability progression significantly more than Aubagio.
Potential Risks: The most common adverse reactions reported from clinical trials were upper respiratory infection, increases in liver function tests, and high blood pressure. History of current or prior immune-suppressing medications may cause Ponvory to further reduce the ability to fight infections. Ponvory is not recommended for people with certain types of heart conditions and people with severe, untreated sleep apnea.
In addition, prescribing information includes several warnings and precautions, including the following. Ponvory:
  • reduces white blood counts, and so may increase the risk of infections, including serious infections
  • may cause a problem with vision called macular edema (swelling in the back of the eye)
  • may cause transient decreases in heart rate
  • may increase the risk of skin cancer
  • may cause breathing problems
  • may cause liver problems
  • may increase blood pressure
  • may cause swelling and narrowing of the blood vessels in the brain, which may lead to stroke
  • may cause harm to a fetus, so women of childbearing potential should use contraception during and for 1 week after stopping Ponvory
  • may cause severe disability after stopping Ponvory
The Ponvory Medication Guide (starting on page 30) provides advice to individuals taking Ponvory about symptoms (side effects) to be alert to and when to inform their healthcare providers about them.
Pre-dosing Tests and Evaluations:
The prescribing information contains advice to healthcare providers about tests people should undergo before beginning to take Ponvory. These include:
  • Complete blood count
  • Liver function tests
  • Eye examination
  • Electrocardiogram/cardiac evaluation
  • Blood test for antibodies to varicella zoster virus (Shingles virus). In those who are negative, VZV vaccination is recommended. If live attenuated vaccine immunizations are required, they should be administered at least 1 month prior to initiation of Ponvory.
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider, taking into account a variety of factors, including the effectiveness of any therapy they are currently taking, and weighing potential risks and benefits, costs, and lifestyle factors.
Read more about medications for MS
Aubagio is a registered trademark of Sanofi Genzyme
Avonex is a registered trademark of Biogen
Gilenya is a registered trademark of Novartis
Mayzent is a registered trademark of Novartis
Zeposia is a registered trademark of Celgene Corporation
Ponvory is a trademark of Janssen Pharmaceutical Companies of Johnson & Johnson

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Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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