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Home Industry News Galderma receives EU approval for facial redness gel

Galderma receives EU approval for facial redness gel

28th February 2014

Galderma has been granted regulatory approval to market its Mirvaso facial redness gel across Europe.

Following two one-month phase III trials of the treatment, which is also known by its chemical name brimonidine, the European Commission has granted authorisation for the drug to be used for patients with facial erythema of rosacea. The studies collected data from 553 patients.

Alison Layton, consultant dermatologist at Harrogate and District NHS Foundation, welcomed the decision, noting there has been a distinct lack of clinically-approved treatments for the condition.

"Mirvaso can play a key role in the treatment of facial redness, potentially giving [patients] a better quality of life," she added.

The alpha-2 adrenergic receptor agonist is a once-daily, long-acting treatment, which Galderma states will begin to reduce redness within 30 minutes of application.

Mirvaso was approved by the US Food and Drug Administration last year and the company said it has witnessed "widespread adoption" of the drug among American dermatologists.ADNFCR-8000103-ID-801699347-ADNFCR

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