The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human Use.
The CHMP called for an update to “clarify the preferred and less favored options for clinical programs with antibacterial agents expected to address an unmet need.”
The CHMP’s infectious disease working group also recommended the clarification of clinical data requirements used to support new combinations of known beta-lactam agents with new beta-lactamase inhibitors and the clarification of considerations for accepting single pivotal studies to support infection site-specific and pathogen-specific indications.
In addition, the proposal calls for adding guidance on clinical trials to support indications for uncomplicated UTIs and gonorrhea.
Agreements reached at recent meetings with the FDA and Japan’s Pharmaceuticals and Medical Devices Agency concerning primary analysis populations, non-inferiority margins and other trial design elements to support major infection site-specific indications, should also be incorporated into the merged guidance, EMA said.
The agency set a comment deadline of Sept. 13, 2018, and it anticipates issuing a final draft in the fourth quarter of 2018.
Read the proposal here: www.fdanews.com/06-14-18-bacterialinfections.pdf. — James Miessler