CLINUVEL (ASX:SUV) says it is in late-stage discussions with the European Medicines Agency (EMA) to increase the recommended maximum number of doses per year of its drug SCENESSE (afamelanotide) for adult patients with erythropoietic protoporphyria (EPP).
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing all aspects of risk management of human medicines. It will decide over the coming months whether to maintain the existing SCENESSE label – including frequency of prescription – or expand it to a higher dosage of up to six times per year.
If approved by the EMA, the European use of SCENESSE would be harmonised with that approved in other jurisdictions, including the US, enabling European EPP patients to receive year-round treatment. The company said an outcome is expected in the first quarter of 2025.
“Over 16,000 doses of SCENESSE have been administered to EPP patients globally, with some patients having received continuous treatment since 2006,” said chief scientific officer Dr Dennis Wright.
“In this time, we have gained extensive knowledge of the product, disorder and its impact on patients’ lives.
“It is apparent from analysing two decades of use, that prescribing a physiological hormone is favourable in EPP, based on the safety data which have been submitted annually to the EMA. Long-term safety is a key advantage over prospective drug candidates in development for EPP.
“CLINUVEL is seeking to harmonise the European dosage and ensure consistency in treatment options globally. Our data package supports this approach and we will continue the exchange with the European regulatory authority which may well recognise the need to provide year-round photoprotection,” added Dr Wright.