Please ensure Javascript is enabled for purposes of website accessibility

FDA Agrees to Review Regeneron's Dupixent for Use by Younger Children

By Todd Campbell - Jan 28, 2020 at 11:36AM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The eczema drug is already approved for patients 12 and older; this proposal would allow it to be prescribed to those as young as 6.

The Food and Drug Administration (FDA) has accepted an application from Sanofi (SNY -1.94%) and Regeneron Pharmaceutical (REGN -0.89%) to review the drug Dupixent for use by children ages 6 to 11 with moderate-to-severe atopic dermatitis (aka, eczema). If approved, Dupixent will become the first biologic medication approved by the FDA for use by this age group.

A boy with clear skin exiting a swimming pool.

IMAGE SOURCE: GETTY IMAGES.

Sanofi and Regeneron already market Dupixent in the U.S. for use by moderate-to-severe eczema patients ages 12 and up. A human monoclonal antibody that targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, Dupixent is a top-selling treatment that had annualized sales exceeding $2.5 billion as of the end of the third quarter of 2019.

The FDA will review Dupixent under an accelerated timeline, which should result in a decision in six months. Approval would allow Sanofi and Regeneron to market Dupixent as an add-on therapy in patients who are responding inadequately to alternative treatments, such as topical corticosteroids.

In phase 3 trials, combining Dupixent with topical corticosteroids improved skin-clearing versus topical corticosteroids alone in 6- to 11-year-olds. Specifically, one-third of patients taking Dupixent every four weeks achieved clear or almost clear skin compared to just 11% of patients taking a placebo. Itching, anxiety, depression, and other factors also significantly improved for patients taking Dupixent.

Trials are ongoing that may clear the way for its use by even younger children someday. A study of Dupixent in pediatric eczema patients ages 6 months to 5 years is underway with results anticipated in a couple of years.

 

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Regeneron Pharmaceuticals, Inc. Stock Quote
Regeneron Pharmaceuticals, Inc.
REGN
$590.13 (-0.89%) $-5.27
Sanofi Stock Quote
Sanofi
SNY
$50.02 (-1.94%) $0.99

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
316%
 
S&P 500 Returns
112%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 07/05/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.