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February 27, 2014

Galderma’s Mirvaso receives European approval for treatment of Rosacea

The European Commission (EC) has granted marketing authorisation in Europe for Switzerland-based pharmaceutical firm Galderma's Mirvaso (brimonidine) 3mg/g gel for the treatment of facial redness, also known as rosacea.

The European Commission (EC) has granted marketing authorisation in Europe for Switzerland-based pharmaceutical firm Galderma’s Mirvaso (brimonidine) 3mg/g gel for the treatment of facial redness, also known as rosacea.

The alpha-2 adrenergic receptor agonist ‘Mirvaso’ reportedly lasts up to 12 hours and is indicated for the symptomatic treatment of facial erythema (redness) of rosacea in adult patients.

Galderma president and CEO Humberto Antunes said: "Applied once-daily, Mirvaso works quickly to reduce the redness of rosacea.

"This is yet another milestone in Galderma’s continued R&D commitment to address the unmet needs of patients with skin conditions."

"Mirvaso offers patients an easy-to-apply, long-acting treatment with visible reductions in facial redness within 30 minutes of application, potentially giving them a better quality of life."

Marketing authorisation was based on data collected from 553 patients enrolled in two Phase III clinical trials of one-month duration.

Results from both studies demonstrated that adults with rosacea erythema who used Mirvaso showed greater reduction of the facial redness than the ones who applied vehicle gel only.

In addition, a long-term study in 449 subjects who used Mirvaso for up to 12-months showed that the gel was effective and well-tolerated.

Harrogate and District NHS Foundation Trust, UK, consultant dermatologist Dr Alison Layton said rosacea is a chronic, inflammatory and vascular disorder affecting the face, with facial redness being a prominent characteristic.

"If left untreated, the condition often has a severe impact on patients’ quality of life," Layton said.

"Up until now there has been no clinically approved treatment targeting the facial erythema of rosacea and Mirvaso can play a key role in the treatment of facial redness.

"Mirvaso offers patients an easy-to-apply, long-acting treatment with visible reductions in facial redness within 30 minutes of application, potentially giving them a better quality of life."

The marketing authorisation for Mirvaso is applicable to the 28 member states of the European Union (EU), as well as Iceland, Lichtenstein and Norway.

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