Gepotidacin

FDA accepts GSK's marketing application for gepotidacin, an oral antibiotic for uUTIs in females, granting Priority Review with a PDUFA date of March 26, 2025. Gepotidacin, part-funded by BARDA, showed non-inferiority to nitrofurantoin in phase 3 trials and potential as the first new oral antibiotic class for uUTIs in over 20 years.

GSK seeks FDA approval for gepotidacin, an oral antibiotic for uncomplicated urinary tract infections, potentially the first in a new class in over 20 years. The FDA granted Priority Review with a PDUFA date of March 26, 2025, based on phase 3 trials showing non-inferiority and superiority to nitrofurantoin.

FDA accepts GSK's NDA for gepotidacin, a novel oral antibiotic for uUTIs, with a PDUFA action date of 26 March 2025. Gepotidacin, supported by positive EAGLE-2 and EAGLE-3 trials, could be the first new class of oral antibiotic for uUTIs in over 20 years.

Indian drugmakers urged to focus R&D on antibacterial and anti-fungal medicines, aligning with public health needs, especially for LMICs. ATMF highlights the global shortfall in developing replacement antibiotics against AMR, stressing the need for early access programs and broader registrations to combat superbugs and save lives.