Ameluz approved by European Commission for treatment for actinic keratosis
pharmafile | March 11, 2020 | News story | Research and Development | EC, EMA, Europe, Lesions
Biofrontera AG has announced the European Commission has approved the use of their drug Ameluz in combination with photodynamic therapy (PDT) for the treatment of actinic keratosis on the extremities and trunk/neck.
The approval was based on a positive reaction by the European Medicines Agency based on the results of one Phase III trial. This included 50 patients, across six centres in Germany, where patients with four to ten confirmed AK lesions each in comparable areas on the right and left side of the extremities and trunk/neck were treated. Patients were treated with Ameluz on one randomly selected side, the other side was treated with placebo.
The PDT was repeated three months later if lesions remained on both sides of the body. The final evaluation of the patients for determination of the study’s primary endpoint took place three months after the last PDT.
The primarily regulatory endpoint showed the Ameluz was superior to placebo based on its mean total lesion clearance rate of 86% compared to 33% for placebo.
Dr. Hermann Lübbert, CEO of Biofrontera AG, commented on the approval, saying: “We are very pleased about the extended label now approved for Ameluz in the EU. Our outstanding results in the treatment of AK on all body regions confirm the excellent efficacy of PDT with Ameluz. We expect that the extension of the approval will further strengthen the market positioning of Ameluz in Europe.”
Conor Kavanagh
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