16 October 2017
I am addressing you during quite a turbulent period, when our teams are preparing various dossiers to meet regulatory obligations in Europe and the US. As recently shared through the ASX, we are inching towards the complete new drug application (NDA) submission and are increasing the data package with European data from the first year of “real-life data” since SCENESSE® (afamelanotide 16mg) was launched in European markets.1 Data analyses are under way and require our teams to critically evaluate clinical reports by hospitals and patients. Here we focus on safety data, frequency, timing, duration, and start and finish of reported side effects. The most common adverse reactions – in more than 10% of first time recipients of SCENESSE® – remain as per the EU Summary of Product Characteristics (transient headaches and nausea), although we continuously monitor the drug’s safety profile. The European analyses will serve as complementary information for the US Food and Drug Administration (FDA).