FDA relaxes SCENESSE postmarketing requirement

• Cardiac study no longer needed after regular safety data reviews
• SCENESSE remains the only FDA-approved medication for erythropoietic protoporphyria (EPP)
• Longitudinal data on SCENESSE demonstrated good human safety

CLINUVEL PHARMACEUTICALS LTD announced that the U.S. Food and Drug Administration (FDA) has reviewed the long-term safety profile of SCENESSE (afamelanotide) and removed a requirement for a post-authorization phase I study on cardiac repolarization (a 'QT study'). Most new drugs approved by the FDA include strict postmarketing requirements to capture additional data, but the FDA has determined that a QT study was no longer needed as it would not provide useful safety information, reflecting the drug's longer-term safety profile. SCENESSE is the only treatment for erythropoietic protoporphyria (EPP) patients approved by any of the global regulatory agencies with over 20,000 doses administered to EPP patients worldwide. CLINUVEL has maintained frequent dialogue with the agency, including compliance with annual reporting requirements and Periodic Adverse Drug Experience Reports, since marketing authorization in 2019, providing extensive data on the short- and long-term safety profile in clinical and real-world conditions.