FDA approves NDA for Ameluz topical gel 10% to increase maximum dosage for actinic keratosis
The FDA has approved the supplemental new drug application for Ameluz topical gel 10% to increase the maximal dosage from one to three tubes per treatment of actinic keratosis, This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients
The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz..The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz.
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