Mirvaso Approved by the European Commission

February 26, 2014

The European Commission has granted marketing authorization in Europe for Galderma's Mirvaso (brimonidine) 3 mg/g gel.

Mirvaso, an alpha-2 adrenergic receptor agonist that acts rapidly and can last for up to 12 hours, is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.

The European Commission decision to grant marketing authorization in Europe for Mirvaso is based on data collected from 553 patients enrolled in two Phase III clinical trials of one-month duration. The results from both studies showed that adults with rosacea erythema who used Mirvaso demonstrated significantly greater reduction of the facial redness than the ones who applied vehicle gel only. In addition, a long-term study in 449 patients who used Mirvaso for up to 12-months demonstrated that Mirvaso was effective and well tolerated.

Mirvaso is the only approved medicinal product that directly targets the facial redness of rosacea and provides an innovative therapy for the condition. Applied once-daily, Mirvaso works quickly to reduce the redness of rosacea,” said Humberto C. Antunes, President and CEO of Galderma. “This is yet another milestone in Galderma's continued R&D commitment to address the unmet needs of patients with skin conditions.”

For more on Mirvaso, which is also FDA-approved for the topical treatment of the facial erythema of rosacea in adults 18 years of age or older, visit http://bit.ly/1gCEBTR

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