CUV announced that it has submitted a marketing authorisation application (MAA) for its drug afamelanotide (16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of afamelanotide as a prophylactic treatment in adult patients with erythropoietic protoporphyria (EPP), a rare disease which causes absolute intolerance of patients’ skin to light. Approval would allow CUV to market afamelanotide in all 27 European Union member states as well as Norway, Iceland and Lichtenstein. This news is in line with our timelines. We expect a MAA decision in the EU in CY12. The EMA aims to complete a MAA review within 210 days after submission.
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