Leveraging the Benefits of the 505(b)(2) Drug Development Approach

Innovation is advancing Prurisol—an oral psoriasis drug candidate in a Phase 2b trial in moderate-to-severe chronic plaque psoriasis—into the clinic by utilizing the advantages of the 505(b)(2) development approach. A drug’s road to market approval can be significantly shortened and at a much reduced cost because the FDA can rely on the safety data from an already approved reference drug—in the case of Prurisol, its bioequivalent, Ziagen. Only one Phase III trial may be required, enrolling fewer patients than is typical. 

Unsurprisingly, an increasing number of pharmaceutical companies are choosing this development approach, saving substantial time and money by leveraging existing research and data: “Twenty-five of the 56 505(b)(2)s approved in 2014 were new formulations of existing drugs, while 16 of the 56 were new doses of existing drugs. In four cases, manufacturers sought approval for a previously unapproved drug based on existing studies not entirely conducted by the sponsor.”

Source: http://www.raps.org/Regulatory-Focus/News/2015/04/08/21933/An-Increasing-Number-of-Companies-Are-Using-a-Once-Obscure-FDA-Drug-Approval-Pathway/

Source: https://camargopharma.com/