Scenesse (afamelanotide 16mg) has its first launch in the Netherlands to treat erythropoietic protoporphyria.- Clinuvel Pharmaceuticals
Clinuvel Pharmaceuticals Limited announced that its drug Scenesse (afamelanotide 16mg) has been launched in Europe, with the first commercial delivery of the product under European marketing authorisation. Patients with the rare genetic disorder erythropoietic protoporphyria (EPP) in the Netherlands will be first to be treated with Scenesse. Treatments in Austria and Germany are expected in July.
The Netherlands is home to one of the largest known adult EPP patient populations in Europe. Following acceptance of the drug as a specialty hospital product by Dutch authorities, Scenesse holds the distinction of being the first ever approved standard of care for EPP, enabling reimbursement of the product for all adult EPP patients in the Netherlands.
Comment: Scenesse has an "exceptional circumstances" marketing authorization, meaning that comprehensive data on the product may never become available or it would be unethical to gather those data. It was also unusual in that it involved a high degree of patient input during the evaluation process at the EMA.
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