Pharmaceutical development is undergoing a defining shift following the ever-increasing regulatory rigor in the process of evaluating a new product. Our recent announcement reflects the conservative view we hold on 21st century drug development.
During development the innovator often seeks to create a market for the new product, a common concept applicable to various industries. The same holds true for afamelanotide: we identified and developed our lead product in an under-served market of porphyria. Adaptation to chemistry and technology, novel communication platforms, deep knowledge and relationships with academia facilitated today’s entry to market.
In past communiqués, we introduced the notion of novel online channels recognising that the introduction of social media had accelerated the knowledge on medicinal UV and light protection. Here we have had much ground to cover worldwide, but despite all efforts, ultimately pharmaceutical development is being steered by the end users: physicians and patients.
The merits of our product needed to be assessed against the mid and long term safety. We have arrived at this point now. However, drug safety and monitoring of the drug’s effects on human organs – expressed in professional terms as toxicology – is to be prioritised at each stage of development. The scientific teams at Clinuvel continuously monitor new toxicology studies in various animal species, whereby human trials equally provide daily data. Thus far, our teams are satisfied with the safety profile and outcome, but only upon final review stage will we know whether the regulatory agencies will approve and accept afamelanotide.
Despite this, today’s unaccounted Italian regulatory news bodes well for a wider acceptance of afamelanotide for erythropoietic protoporphyria (EPP). Most positive is that we are once again confirmed in our view that 21st century drug development will become more and more driven by physicians and patients, the strongest basis of the pharmaceutical sector.
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