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.
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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.”
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.
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By GlobalDataIn 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.
