Gepotidacin

Phase 3 data highlight zoliflodacin and gepotidacin as promising oral treatments for gonorrhea, including drug-resistant strains. Zoliflodacin showed a 90.9% cure rate, while gepotidacin achieved 92.6%, both comparable to current treatments. These findings suggest new options for combating resistant gonorrhea infections.

Q1 2025 anticipates 5 key FDA decisions: AXS-07 for acute migraine, NT-501 for Macular Telangiectasia type 2, Vutrisiran for ATTR-CM, Gepotidacin for uUTIs, and Etripamil Nasal Spray for PSVT, promising advancements in treatment paradigms.

FDA approves oxycodone hydrochloride for severe pain, sulopenem etzadroxil and probenecid for uncomplicated UTIs, Pfizer's Abrysvo for RSV in adults 18-59, marstacimab-hncq for hemophilia B, Imuldosa biosimilar to Stelara, Bayer's elinzanetant for menopause symptoms, and gepotidacin for uncomplicated UTI.

GSK's RSV vaccine Arexvy sales dropped 72% in Q3 due to narrower US recommendations and COVID-19 vaccination prioritization. Pfizer's Abrysvo sales declined only 5%, suggesting Pfizer's ascendency in the RSV vaccine market. GSK's overall vaccine sales fell 15%, leading to a revised forecast of low-single-digit percentage gains. Despite this, GSK's overall revenues increased 2% to $8 billion, supported by HIV drugs and specialty medicines.

GSK delivered Q3 sales and core operating profit growth, with strong specialty medicines offsetting lower vaccine sales. The pipeline strengthened with 11 positive phase III trials and 5 major product launches planned for next year. Zantac litigation was resolved, aligning with 2024 guidance and bolstering confidence in 2026 and 2031 outlooks. Forward-looking statements are subject to risks and uncertainties.

GSK Q3 2024 results: £8.0 billion sales (-2% AER, +2% CER), driven by Specialty Medicines (+19%) offsetting Vaccines (-15%). Core operating profit +5%, Core EPS +5%. R&D progress includes EU approval for Arexvy, HIV PrEP effectiveness, and oncology breakthroughs. 2024 guidance confirmed: 7-9% turnover growth, 11-13% Core operating profit growth, 10-12% Core EPS growth, excluding COVID-19 solutions.

FDA grants Priority Review to GSK’s gepotidacin NDA for uncomplicated uUTIs in females and adolescents, supported by Phase III EAGLE-2 and EAGLE-3 trials showing non-inferiority to nitrofurantoin. Gepotidacin demonstrated therapeutic success rates of 58.5% and 50.6% in EAGLE-3 and EAGLE-2, respectively, compared to 43.6% and 47% for nitrofurantoin. Safety and tolerability consistent with previous trials, with common AEs being gastrointestinal.

GSK's gepotidacin, an oral antibiotic for uncomplicated urinary tract infections, has been accepted for priority review by the FDA, with a decision expected by 26 March 2025. The drug targets drug-resistant bacteria and is supported by positive EAGLE-2 and EAGLE-3 trial results.

FDA accepts NDA for gepotidacin (GSK) for uUTIs in females 12+; grants Priority Review with action date in March 2025. If approved, gepotidacin could be the first-in-class oral antibiotic for uUTIs in over 20 years. Phase 3 trials (EAGLE-2, EAGLE-3) showed gepotidacin's non-inferiority and superiority to nitrofurantoin, with common adverse events being diarrhea and nausea.