Biofrontera Files Label Extension for Ameluz® in EU to include Treatment of Actinic Keratosis on Extremities and Trunk/Neck
Biofrontera AG - American Depositary Shares (BFRA)
US:NASDAQ Investor Relations:
biofrontera.com/en/investors/financial-reports.html
Company Research
Source: GlobeNewswire
Leverkusen, Germany, Sept. 17, 2019 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, has filed a label extension for Ameluz® with the European Medicines Agency (EMA) on August 28, 2019 to include treatment of mild and moderate actinic keratosis (AK) of the extremities and trunk/neck with photodynamic therapy (PDT). The submission follows the positive treatment outcomes demonstrated for Ameluz® in the recent phase III trial. "The label extension for the treatment of actinic keratosis of the trunk and extremities is a further step in our strategic efforts to expand the market for Ameluz®," says Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG. "Our excellent results in the treatment of AK on these body regions, which are particularly difficult to treat, confirm the excellent outcome of PDT with Ameluz®. The EMA has confirmed the validity of our submission and will comment on the status of th
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