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Home Industry News Galderma receives European approval for rosacea cream Soolantra

Galderma receives European approval for rosacea cream Soolantra

27th March 2015

Galderma has announced that its new Soolantra cream for the treatment of rosacea has been approved in the EU via the European Decentralised Procedure.

The Medical Products Agency of Sweden acted as reference member state for this process, acting on behalf of 28 EU states, all of which have agreed that the once-daily topical cream  should be approved for treating inflammatory lesions of papulopustular rosacea in adult patients.

Data from three phase III studies involving more than 2,300 subjects have demonstrated the efficacy benefits that Soolantra can offer compared to established alternative therapy options.

Rosacea is a common inflammatory skin disease often characterised by erythema, papules and pustules. Soolantra acts against the disease using the active ingredient ivermectin, which offers anti-inflammatory and anti-parasitic properties.

Stuart Raetzman, chief executive officer of Galderma Pharma, said: "A clear focus on skin health has helped us expand our rosacea franchise to deliver more medicines that offer a novel approach, addressing important patient needs."

Galderma is owned by Nestle, which is increasing its focus on dermatology following the recent launch of its Nestle Skin Health business. Mr Raetzman was installed as Galderma's head earlier this month.ADNFCR-8000103-ID-801781567-ADNFCR

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