Moberg Pharma AB (publ) have submitted its marketing authorization application for MOB-015 (nail fungus treatment). The company has submitted the application in Europe through the decentralized procedure, and market approval is expected in 2023.
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Moberg Pharma have submitted a full application, which offers the possibility of data exclusivity in Europe for up to ten years following market approval. The Swedish Medical Products Agency is the reference member state and will lead the review of the application. The company’s goal is to receive its first market approval and launch MOB-015 in 2023.
“Submitting the Marketing Authorization Application in Europe is a key milestone in our journey to launch a new and improved nail fungus drug. MOB-015 is uniquely positioned through its high antifungal efficacy, since there is significant need for a treatment that truly cures the nail infection,” says Anna Ljung, CEO of Moberg Pharma AB.