EU approves Soolantra (ivermectin) via decentralised procedure to treatrosacea- Galderma

Galderma, a global specialty pharmaceutical company focused on dermatology, has announced a positive outcome of the European Decentralised 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 EU Member States, which all agreed that Soolantra Cream can be approved.

The Marketing Authorisation application of Soolantra Cream was based on three Phase III studies, which involved over 2,300 subjects. Two 12-week treatment vehicle-controlled studies demonstrated superiority of Soolantra Cream efficacy over vehicle cream within 4 weeks. In a 16-week treatment active-controlled study, Soolantra Cream was shown to be superior to Metronidazole 7.5 mg/g cream twice-daily in reducing Inflammatory Lesion Counts (ILC) as of Week 3 and until Week 16. After 16 weeks of treatment with Soolantra the reduction in ILC reached 83.0% from baseline. This is reflected in the European prescribing information.