Melbourne, Australia and Leatherhead, UK, 29 March 2019
CLINUVEL PHARMACEUTICALS LTD today announced that it will host national expert meetings in Berlin, Germany, on 29 March and Florence, Italy, on 5 April to evaluate the treatment of erythropoietic protoporphyria (EPP).
Clinicians and medical staff from a number of EPP expert centres will participate in the full day meetings, focused on clinical treatment of adult EPP patients, results from the ongoing post-authorisation safety study (PASS) in Europe, and the clinical findings of treatment with SCENESSE® (afamelanotide 16mg)1. Discussions will also be held on broader treatment experiences in European countries and the development of a treatment protocol for children with EPP.
EUROPEAN POST-AUTHORISATION COMMITMENTS
SCENESSE® was approved for the prevention of phototoxicity in adult EPP patients by the European Medicines Agency (EMA) in 2014. As part of the approval, CLINUVEL and the EMA agreed a strict risk management plan to monitor the long-term safety and use of the product, including controlled distribution and the collection and annual reporting of pseudonymised data through the European EPP Disease Registry (EEDR) under the PASS.
The most recent annual report – submitted to the EMA in January 2019 – confirmed the safety profile of SCENESSE® was unchanged compared to the approved Summary of Product Characteristics (SmPC). Ongoing treatment compliance, a measure of effectiveness based on patients continuing treatment year-on-year, was found to be 98.5%. Data from this report will be presented and discussed with experts at the two meetings.
EPP is a lifelong metabolic disorder which first presents after birth. Under a paediatric investigation plan to the European Medicines Agency, CLINUVEL has committed to developing a dose of afamelanotide which is suitable for children with EPP. Feedback from the Company’s ongoing program for adult patients in Europe is being used to advance this program, with clinical input essential to understanding how best to develop a paediatric product.
“CLINUVEL has sought to engage with experts throughout the development of the first ever treatment for EPP patients and it is a privilege to be able to continue this dialogue,” CLINUVEL’s Director of Clinical Affairs, Dr Emilie Rodenburger said. “These meetings enable our team to receive direct feedback and complement the real world evidence captured in the EEDR to help improve our post-authorisation and R&D programs. By presenting data and fostering debate and discussion, our teams and the experts can also work together to improve the support and lifelong care we can provide to patients.”