Evidence required for approval of novel mechanisms of action An investigational product, for which there is little to no precedence for a related indication, may require more data versus an established product where the possibility may exist to extrapolate from pre-existing data. The guideline should provide guidance where 2 randomised controlled trials are required versus a single well designed randomised controlled trial. For instance, for a product approved in a related indication (eg PsA, RA), where there is therefore supporting safety data, a single well-controlled study with compelling data may suffice.
Evidence required for approval of novel mechanisms of action An investigational product, for which there is little to no precedence for a related indication, may require more data versus an established product where the possibility may exist to extrapolate from pre-existing data. The guideline should provide guidance where 2 randomised controlled trials are required versus a single well designed randomised controlled trial. For instance, for a product approved in a related indication (eg PsA, RA), where there is therefore supporting safety data, a single well-controlled study with compelling data may suffice.