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Galderma: European Commission OKs marketing of Mirvaso for rosacea erythema

Galderma announced that the European Commission has given marketing authorization for its brimonidine topical gel for treating facial erythema of adult rosacea.

The 3 mg/g gel is an alpha-2 adrenergic agonist that reportedly lasts up to 12 hours and has the proprietary name Mirvaso, endorsed by the European Medicines Agency. The FDA approved Mirvaso for treatment of facial erythema of adults with rosacea in 2013.

“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,” Alison Layton, MB, ChB, MRCP, FRCP, consultant dermatologist at Harrogate and District NHS Foundation Trust, UK, said in a press release.

The authorization was based on data from two phase 3, 1-month clinical trials of 553 patients, according to the release. Patients who used Mirvaso displayed significantly greater reduction in facial rosacea erythema compared with those who only applied vehicle gel. Four hundred forty-nine participants used Mirvaso for up to 1 year in a long-term study showing the product to be effective and well-tolerated.

The marketing authorization includes 28 member states of the European Union, plus Iceland, Lichtenstein and Norway, according to the release.