Clinuvel has announced today that Italy has pre-empted the approval of Afamelanotide by the FDA in the US by approving it for the treatment of erythropoietic protoporphyria (EPP).
Despite the relatively small number of participants in the Italian trial to treat EPP, and the small number of EPP sufferers thought to directly benefit from this therapy, the approval by Italian Medicines Agency (AIFA) is significant because it confirms Afamelanotide’s efficacy and safety and also that national medicine agencies are willing to rapidly approve afamelanotide.
Clinuvel have also announced that afamelanotide will be marketed under the brand name of Scenesse (pronounced “sen-esse”). From today onwards, Clinuvel will adopt SCENESSE in all references to the drug in its further global clinical development.
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