Galderma’s new Epiduo formulation recommended for European approval

Galderma has received a positive opinion from 16 relevant European regulatory agencies for EU market approval of a new formulation of its acne therapy Epiduo.

The adapalene/benzoyl peroxide gel is indicated for the cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present. A once-daily application in the evening can result in early signs of clinical improvement after one to four weeks of treatment.

This new formulation contains a fixed-dose combination of three mg/g of adapalene and 25 mg/g of benzoyl peroxide. It offers a higher concentration of adapalene than the previous formulation, providing increased clinical benefit in subjects with numerous papulopustules.

Galderma's marketing authorisation application for the new gel was based on positive results from a 12-week clinical study involving 503 patients.

Thibaud Portal, global vice-president for prescriptions at Galderma Pharma, said the development of Epiduo "demonstrates Galderma's constant commitment to advancing dermatology and delivering innovative medical solutions to healthcare professionals".

Following this recommendation, Galderma expects the gel to be available in pharmacies across Europe from 2017 onwards.

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