Galderma Receives Positive Opinion Through European Decentralised Procedure for Approval of EPIDUO® 0.3% / 2.5% gel (adapalene / benzoyl peroxide) for Acne Patients[1]

PARIS, September 27, 2016 /PRNewswire/ --

Galderma today announced that it has received a Positive Opinion from 16 concerned European regulatory agencies^[2] for the market approval of EPIDUO 0.3% / 2.5% gel (adapalene/ benzoyl peroxide), for the cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present^[3] .

"Moderate to severe acne vulgaris is a debilitating condition that can have tremendous impacts on sufferers' social lives and self-esteem. The approval of EPIDUO 0.3% / 2.5% gel by the European Health Authorities will bring relief to patients suffering from this condition. It demonstrates Galderma's constant commitment to advancing dermatology and delivering innovative medical solutions to healthcare professionals" said Thibaud Portal, Global Vice President of Prescription, Galderma Pharma, S.A.

With a once-daily application of EPIDUO 0.3% / 2.5% gel in the evening to the entire affected areas of the face and the trunk, early signs of clinical improvement usually appear after 1 to 4 weeks of treatment^[3]. Galderma expects EPIDUO 0.3% / 2.5% gel to be available in pharmacies in Europe as of 2017.

EPIDUO 0.3% / 2.5% gel contains a fixed-dose combination of Adapalene (3 mg/g) and Benzoyl Peroxide (BPO, 25 mg/g) as EPIDUO 0.1% / 2.5% gel, but with a higher concentration of Adapalene, which provided increased clinical benefit in the subjects with numerous papulopustules treated with EPIDUO 0.3% / 2.5% gel compared with the lower strength^[4].

Adapalene belongs to a group of topical products known as retinoids and acts specifically on the skin processes that cause acne. BPO works as a non- antibiotic antimicrobial agent and by softening and peeling the outer layer of the skin^[5],^[6]. All these assets have made EPIDUO 0.1% / 2.5% the number 1 prescribed topical acne medication in the world^[7].

The Marketing Authorisation application of EPIDUO 0.3% / 2.5% gel was based on a 12-week, multicenter, randomised, double-blind, controlled clinical study, which involved 503 patients with an acne severity assessed as "moderate" (IGA3) or "severe" (IGA4) at baseline (50% in each subgroup)^[8]. EPIDUO 0.3% / 2.5% gel is the only approved topical product studied with at least half of patients being severe (IGA4). EPIDUO 0.1% / 2.5% gel was included in the trial as a reference therapy. In the analysis in subjects graded as "severe", EPIDUO 0.3% / 2.5% gel achieved a greater efficacy over vehicle with a treatment difference of 20.1%, whereas the reference therapy did not^[3].

Two different strengths of EPIDUO (0.1% / 2.5% and 0.3% / 2.5%) are now available^[3]. Doctors may choose between the two concentrations based on the presenting patient's clinical condition and severity^[3]. EPIDUO 0.3% / 2.5% gel is a once-daily topical treatment option consistent with current dermatology guidelines^{[9],[10],[11],[14]} which recommend both a topical retinoid and a topical antimicrobial agent as a first line therapy for the majority of acne patients.

What is Acne?  

Medically known as acne vulgaris, it is the most frequently diagnosed disease among dermatologists^[12]. Acne is a distressing chronic inflammatory skin disease of the pilosebaceous unit that can cause significant scarring of the skin. 99% of scars originate from inflammatory (papules and pustules) and post-inflammatory lesions^[13]. Acne vulgaris is a chronic inflammatory skin affects approximately 80% of young adults and adolescents^[14]. Acne is also becoming more prevalent in adulthood. A significant number of patients either continue to experience acne or develop new-onset acne after the teenaged years^[15].This is a polymorphic disease in which several types of lesions are usually present concurrently: primary (including non-inflammatory and inflammatory types) and secondary lesions which originate from primary lesions (including scars and post-inflammatory erythema, post-inflammatory dyspigmentation)^[9]. Acne can persist for years and may seriously affect the psychosocial development of the patient, resulting in emotional problems, withdrawal from society, and depression^[16]. If people suspect that they might have acne, they should visit their dermatologist or healthcare provider for diagnosis and treatment.

When it comes to acne treatment, long-term use of antibiotics may be a contributing factor to the overall global antibiotic resistance issue. Propionibacterium acnes (P. acnes), a bacteria linked to acne, is increasingly becoming resistant to topical and oral antibiotics, which may potentially cause a decrease in treatment efficacy against acne^[17].

About Galderma 

Dating back to 1961, Galderma is now present in 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care professionals around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin, hair and nails. For more information, visit http://www.galderma.com

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1. EPIDUO is a trademark owned by Nestlé Skin Health

2. The 16 EU countries are: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, United Kingdom

3. EPIDUO Forte 0.3%/2.5% Prescribing Information

4. Weiss et al. Customized Single-agent Therapy Management of Severe Inflammatory Acne: A Randomized, Double-blind, Parallel-group, Controlled Study of a New Treatment - Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel. Journal of Drugs in Dermatology, Volume 14, Issue 12, December 2015

5. Dréno B, et al. J Eur Acad Dermatol Venereol 2015;29(54):3-11;

6. Gollnick H, et al. J Eur Acad Dermatol Venereol 1998;11(Suppl 1):S8-12;

7. IMS Health database, IMS MIDAS. December 2015

8. Stein Gold et al. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled StudyAm J Clin Dermatol 2016

9. Nast, A., et al (2016), European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol, 30: 1261-1268. doi:10.1111/jdv.13776

10. New insights into the management of acne: An update from the Global. Alliance to Improve Outcomes in Acne Group. J Am Acad Dermatol. 2009 May;60 (5 Suppl):S1-50. doi: 10.1016/j.jaad.2009.01.019.

11. Zaenglein, Andrea L. et al. (2016) Guidelines of care for the management of acne vulgaris Journal of the American Academy of Dermatology , Volume 74 , Issue 5 , 945 - 973.e33

12. Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet 2012; 379:361-372.

13. Bourdes, V. et al. Natural history of acne lesions and atrophic acne scars within a 6-month study period poster presented at: WCD 2015

14. Gollnick H, Cunliffe W, Berson D, et al. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003;49(1 Suppl):S1-37.

15. Collier et al. The prevalence of acne in adults 20 years and older, American Academy of Dermatology, 2008

16. Dréno, B., Tan, J., Kang, S. et al. Dermatol Ther (Heidelb) (2016) 6: 207. doi:10.1007/s13555-016-0113-x

17. O'NEILL J. The review on antimicrobial resistance. Tackling drug-resistant infections globally: final report and recommendations may 2016