The FDA has published guidance to support the submission process for companies developing fixed-dose combinations (FDCs) for the treatment of HIV patients. According to this guidance, “FDCs are essential for the treatment of HIV/AIDS…They are consistent with the goal of HIV therapy—to maximally and durably suppress virus to allow the recovery of the immune system and reduce the emergence of HIV resistance.”
However, the FDA has also stated that there are some antiretrovirals that should not be combined due to overlapping toxicities and potential viral antagonisms. Numerous studies show that FDCs improve adherence and reduce costs, but those factors don’t make an extremely time-consuming and complex development and approval process any less challenging.
Nonetheless, according to Sean Dalziel, Managing Director and Co-founder of Actera Pharmaceuticals, a formulation innovation company specializing in FDCs, “Now that drug development companies receive five years of marketing exclusivity for newly approved NCEs, even where first registered in the context of an FDC, companies can invert their sequence of FDC lifecycle development without an exclusivity penalty.”