The European Commission has approved the use of Biofrontera’s topical prescription drug, Ameluz, in combination with daylight Photodynamic Therapy (daylight PDT). The approval for daylight PDT is expected to greatly increase the market potential for Ameluz in Europe, and to improve the drug’s reimbursement status in Germany.
The approval by the European Commission followed a positive opinion by the European Medicines Agency and is based on a phase 3 trial comparing Ameluz side-by-side with its competitor Metvix. While the difference in clearance rates was only minor between both products three months after treatment, statistically significant differences became apparent during the one-year follow-up period. Three months after a single treatment with daylight PDT, 79.8 percent of the Ameluz and 76.5 percent of the Metvix patients were fully cleared.
One year after the treatment, however, 19.9 percent of the lesions were recurrent after Ameluz PDT and 31.6 percent after Metvix PDT, respectively (p<0.01). Recurrence rates for more difficult to treat lesions, such as moderately thick lesions or lesions on the scalp, were 20.5 percent and 23.4 percent for Ameluz, and 34.3 and 43.7 percent for Metvix, respectively (p<0.01). This superior efficacy one year after PDT is expected to facilitate market penetration of Ameluz.
(Source: Biofrontera)
Filed Under: Drug Discovery
