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Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.
Dermatologist-led biopharmaceutical company, Aclaris Therapeutics, has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA (hydrogen peroxide) cutaneous solution, 685 mg.
The topical solution is approved for the treatment of adults with seborrheic keratosis that are not pedunculated and have up to a maximum diameter of 15 mm each. The company has also received marketing approval for the treatment in the United Kingdom, Iceland, Belgium, and Finland.
“In its role as the reference member state, Sweden worked with all concerned member states to establish the approvability of the medicine,” said Christopher Powala, chief regulatory and development officer for Aclaris, in a Feb. 20, 2019 press statement. “We have submitted marketing authorization applications in 10 additional member states within the European Economic Area through the decentralized procedure.”
Source: Aclaris Therapeutics