Efficacy Results

GILENYA relapsing ms treatment results in children

GILENYA was studied in up to a 2-year trial of children between the ages of 10 and less than 18 years of age.

An international study known as PARADIGMS was conducted in 86 sites in over 25 countries. PARADIGMS studied the effectiveness of GILENYA® compared to that of a leading injectable in children ages 10 to less than 18 years of age.

Here are the results:

Cut relapses by 82%

GILENYA was shown to reduce relapses in children as young as 10.

When someone living with relapsing MS experiences new symptoms or the worsening of old symptoms for 24 hours or longer, it's considered a relapse. Here's how GILENYA was shown to help.

GILENYA significantly reduced annualized relapse rate in children

GILENYA significantly reduced the annualized relapse rate in children as young as 10 by 82% over a period of up to 2 years compared with a leading injectable.

Reduced lesions

GILENYA reduced lesions seen on an MRI by more than half.

There are two different types of MRI scans that your child's doctor can use to look for brain
lesions—Gd+ T1 scans and T2 scans.

GILENYA significantly reduced lesions in children by more than half

GILENYA significantly reduced the number of Gd+ T1 lesions seen on an MRI in children as young as 10 by 66% over a period of up to 2 years compared with a leading injectable (0.436 vs 1.282).

GILENYA significantly reduced new or newly enlarging lesions in children

GILENYA significantly reduced the rate per year of new or newly enlarging T2 lesions seen on an MRI in children as young as 10 by 53% over a period of up to 2 years compared with a leading injectable (4.39 vs 9.27).

The time is now

Talk to your child's health care professional about GILENYA today.

DEDICATED PARENT LINE

DEDICATED PARENT LINE

If you still have questions, feel free to call our dedicated parent line at 1-800-598-1410, 8 AM to 9 PM ET, Monday through Friday.*

*Excludes public holidays.

DEDICATED PARENT LINE

WE'RE HERE TO HELP

GILENYA can be affordable for most people—and once your child gets started, you both will have a dedicated Support Specialist on your side.

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SAFETY INFORMATION

Take a look at some important safety information to see if GILENYA may be right for your child.

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Novartis ISI Novartis ISI gpr@quintiles.com www.gilenyapregnancyregistry.com www.fda.gov/Safety/MedWatch
Novartis ISI gpr@outcome.com www.gilenyapregnancyregistry.com www.fda.gov/Safety/MedWatch
Novartis ISI gpr@outcome.com www.gilenyapregnancyregistry.com www.fda.gov/Safety/MedWatch
 
Novartis

Speak up and share your message. Tell multiple sclerosis (MS) how you really feel by posting your message on our "HEY MS" message board.

Make sure your voice is heard. We love that you want to say "Take This!" to relapsing MS, but there are still some words even we can't use—words that might not be appropriate. They're defined in the Community Guidelines below. But have no fear; we'll give you a heads up if you use any problematic words by highlighting them after you hit submit. So, go for it, and tell relapsing MS how you really feel!

  • Do not include medical advice or any non-approved use of GILENYA

  • No profane, indecent, or inappropriate language in your message or image, please (a no-no)

  • Avoid using your full name and/or e-mail address in your message, so this personal information remains private and protected

  • Do not include spam, such as links to or URLs for other websites or social networks in your message

  • Refrain from sharing any treatment and/or dosage information, as well as names of specific medicines (brand name or generic) and product manufacturers

  • Avoid mention of side effects from GILENYA. We take drug product safety seriously. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
    1-800-FDA-1088

Please note that in order to comply with our Community Guidelines as well as the FDA's Prescription Drug Advertising Guidelines, your statement may be subject to modification, while maintaining the spirit of your message. Your photo and statement may be used in other GILENYA marketing materials

 
 

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