EU approval of Galderma’s Soolantra under DCP agreed

Swiss drugmaker Galderma, the operating company of Nestlé Skin Health, has received a positive outcome of the European Decentralized Procedure (DCP) for Soolantra (ivermectin) Cream 10mg/g for the once-daily topical treatment of inflammatory lesions of papulopustular rosacea in adult patients.

The Medical Products Agency (MPA) in Sweden acted as Reference Member State (RMS) on behalf of 28 European Union member states, which all agreed that Soolantra Cream can be approved. Last year, the US Food and Drug administration approved Soolantra cream for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea (The Pharma Letter December 24).

“As a world leader in skin health, Galderma is committed to providing innovative treatment options for clinicians and patients, and the approval of Soolantra Cream highlights our continuous efforts,” said Stuart Raetzman, chief executive of Galderma Pharma SA, adding: “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.”