Unbranded disease mechanism APS for first-in-class product
-
If a product has been recently approved with a novel mechanism of action that targets (for example) a unique signalling pathway, is it acceptable to create an unbranded HCP-directed mechanism of disease APS that focuses on that pathway?
Or would that inherently brand the APS as there is only one treatment available targeting that mechanism of disease?
-
An unbranded APS may be created for physiology or pathophysiology of the signaling pathway. However, the APS may not make reference to potential treatment or exogenous intervention at the target site as that would brand the APS if there are no other agents that work at that target.
