Antibiotic Spring? Regulatory Incentives Spur Activity – And Maybe Medical Advances
Regulatory incentives have been successful at attracting developers to antibiotic R&D, but significant medical advances have stubbornly remained rare. Now the pipeline has produced the first novel antibiotic to receive breakthrough status from US FDA and some Phase III trials are raising the efficacy bar to superiority.
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Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.
Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.
It's too early to say whether program is working, FDA tell Congress; agency has awarded 147 QIDP designations, but none of 12 approved antibacterals have new mechanism of action.