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  5. Drug Trials Snapshot: PONVORY
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Drug Trials Snapshot: PONVORY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the PONVORY Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

PONVORY (ponesimod)
(Pon-VOR-ee)
Janssen Pharmaceuticals, Inc.
Approval date: 03/18/2021


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

PONVORY is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

In relapsing forms of MS, patients have episodes of worsening function (relapses) followed by recovery periods. Patients can also experience an increase in the underlying disability, particularly as the disease progresses.

How is this drug used?

PONVORY is provided as a 14-day starter pack of tablets. The dose must be slowly increased over the first two weeks. PONVORY is then taken once daily at a dose of 20 mg starting on Day 15.

What are the benefits of this drug?

PONVORY was better in reducing the risk of disease relapse in comparison to teriflunomide, a product approved for the treatment of relapsing forms of MS.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: PONVORY worked similarly in males and females
  • Race: The number of patients of races other than White was small; therefore, differences in how well PONVORY worked among races could not be determined.
  • Age: PONVORY worked similarly in patients below and above 40 years of age.

What are the possible side effects?

PONVORY may cause serious side effects including life threatening infections, decreased heart rate, liver injury, increased blood pressure, decreased lung function, and build-up of fluid in the back of the eye (macular edema).

The most common side effects of PONVORY are upper respiratory infections, increased liver enzymes, and high blood pressure.

Were there any differences in side effects of the clinical trials among sex, race, and age?

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: The number of patients of races other than White was small; therefore, differences in the occurrence of side effects among races could not be determined.
  • Age: The occurrence of side effects was similar in patients below and above 40 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved PONVORY based on evidence from a clinical trial (Trial 1/ NCT02425644) of 1133 patients with relapsing forms of multiple sclerosis. The trial was conducted at 162 sites in 28 countries in North America, Europe, Mexico, Israel, and Turkey.

Figure 1 summarizes how many men and women were enrolled in the clinical trial used to evaluate the efficacy of PONVORY.

Figure 1. Baseline Demographics by Sex (Efficacy Population)

Figure 1 is a pie chart summarizing how many participants by sex were evaluated for efficacy in the Study 1 clinical trial.  Of the 1131 participants, 396 (35.1%) were male and 735 (64.9%) were female.

Source: FDA Review

Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the efficacy of PONVORY.

Figure 2. Baseline Demographics by Race (Efficacy Population)

Figure 2 is a pie chart summarizing how many participants by race were evaluated for efficacy in the Study 1clinical trial.  Of the 1131 participants, 1102 (97.3%) were White and 5 (0.4%) were Black; 24 (2.3%) volunteers accounted for all Other races.

Source: FDA Review

Figure 3. Baseline Demographics by Age (Efficacy Population)

Figure 3 is a pie chart summarizing how many participants by age were evaluated for efficacy in the Study 1 clinical trial.  Of the 1133 participants, 737 (65.1%) were ≤40 years and 396 (34.9%) were >40 years of age.

Source: FDA Review

How were the trials designed?

The benefits and side effects of PONVORY were evaluated in a clinical trial of patients with relapsing forms of MS. Patients received PONVORY or comparator for up 2 years. Neither the patients nor the health care providers knew which treatment was being given until the trials were completed.

The benefit of PONVORY was evaluated based on the percentage of patients who experienced reduction in disease relapse in comparison to patients treated with teriflunomide.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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