Fort Worth, Texas – Tuesday, February 19, 2013 – Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Epiduo® (adapalene 0.1%/BPO 2.5%) Gel to treat acne in children as young as 9 years old based on the results of a recent clinical study in pediatric patients. Epiduo® Gel had been previously approved for patients 12 years of age and older.
“Pediatricians and dermatologists are seeing a steady increase in children reaching puberty at an earlier age and, consequently, many children are dealing with acne sooner than traditionally observed,” said Dr. Lawrence Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital, San Diego and at the University of California, San Diego. “Given the nature of acne, and its direct relationship to puberty and hormones, the focus of acne treatment has been on teenagers, leaving the younger age group with limited FDA-approved treatment options. With Epiduo® Gel’s newly approved age indication starting at 9 years-old, pediatricians and dermatologists now have a safe and effective treatment for children with early acne.”
The recent FDA approval is based on data from a recently completed 12-week multicenter, randomized, vehicle-controlled, double-blind pediatric study that evaluated the safety and efficacy of Epiduo® Gel in 285 acne sufferers aged 9 to 11 years.1A Results showed that:
• Epiduo is safe and effective in this younger population known to have more sensitive skin. The results of this pediatric clinical study were similar to those observed in prior Phase 3 clinical studies that included patients 12 years of age and older.
• Nearly 70 percent of parents with children in the Epiduo® Gel treatment group saw improvement in their child’s acne compared to only 23 percent of parents with children on placebo.
• Similar to the prior Phase 3 clinical studies for patients 12 years and older, common side effects reported in this study included skin burning sensation, skin irritation, skin discomfort, dry skin and erythema.
“This expanded pediatric indication for Epiduo® Gel exemplifies Galderma’s real commitment to meeting the needs of all patients who suffer from dermatological conditions, such as acne,” said François Fournier, President, Galderma Laboratories, L.P. “Galderma has always been dedicated to providing physicians with innovative acne solutions, and the new label for Epiduo® Gel underscores our dedication to the dermatology community. We are excited to make this safe and effective treatment solution available to pediatricians and dermatologists who treat acne in patients as young as 9 years old.”
Research has shown that the onset of acne is frequently seen in patients of preadolescent age2, and until now, pediatricians and dermatologists did not have access to a prescription acne product approved for this age group. Treating acne in children as early as 9 years old may help prevent acne scarring in the future.3
Acne vulgaris is the most common skin problem in the United States, affecting about 40 to 50 million Americans at any one time4. Acne appears when skin pores clog, beginning with dead skin cells4. When the body starts to make lots of sebum, dead skin cells can stick together inside the pore. Instead of rising to the surface, the cells become trapped inside the pore4. Sometimes bacteria that live on our skin, p. acnes, also get inside the clogged pore4. Inside the pore, the bacteria have a perfect environment for multiplying very quickly. 4 With loads of bacteria inside, the pore becomes inflamed (red and swollen). 4 If the inflammation goes deep into the skin, an acne cyst or nodule appears. 4
Galderma is a global pharmaceutical company founded in 1981 and exclusively focused on dermatology. The company has 31 wholly-owned affiliates with a worldwide network of distributors and 4,000 employees. Galderma's extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence. In 2011, Galderma acquired Q-Med, a Swedish medical device company specialized in aesthetics, strengthening Galderma's presence in the aesthetic and corrective market.
With approximately 19 percent of revenues invested each year to discover and develop new products and access innovative technologies, the company is one of the world's leading investors in dermatology R&D. Four state-of-the-art R&D centers, of which Sophia Antipolis in France is one of the largest dermatology sites in the world, and four manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy. Strategic brands in the US include Epiduo®, Oracea®, Clobex®, Differin®, MetroGel®, Vectical® and Cetaphil®. For more information, please visit www.galdermausa.com.
Important Safety Information
Indication: EPIDUO® Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (=1%) in patients treated with EPIDUO® Gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. Warnings/Precautions: Patients taking EPIDUO® Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/ burning, irritant and allergic contact dermatitis may occur with use of EPIDUO® Gel and may necessitate discontinuation.
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.
4. Data on file, Galderma Laboratories, L.P.
5. Friedlander SF, Eichenfield LF, Fowler JF Jr, Fried RG, Levy ML, Webster GF. Acne epidemiology and pathophysiology. Semin Cutan Med Surg. 2010;29:2-4.
6. Thiboutot D, Gollnick H,Bettoli V, et al; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the GlobalAlliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009;60(5)(suppl):S1-S50.
American Academy of Dermatology. Acne: Who gets and causes. Accessed at: https://www.aad.org/skin-conditions/dermatology-a-to-z/acne/who-gets-causes on February 4, 2013.