GSK announced that the U.S. Food and Drug Administration (FDA) has accepted its application for priority review of gepotidacin, an oral antibiotic for the treatment of sexually transmitted, uncomplicated urogenital gonorrhoea. The FDA’s decision is expected by December 11.
The application covers patients aged 12 years and older who weigh at least 45 kilograms (99 pounds). If approved, the drug would provide an oral treatment option for a condition that is currently managed with injectable therapies. Gepotidacin is already approved in the United States under the brand name Blujepa for treating uncomplicated urinary tract infections in women and adolescent girls.
In a phase 3 trial, gepotidacin demonstrated non-inferiority to intramuscular ceftriaxone and oral azithromycin, a leading treatment regimen for gonorrhoea. GSK stated, “If approved, the drug would become the first oral option in this indication.”
The company said it is looking to expand its infectious disease portfolio, which includes its recently launched respiratory syncytial virus vaccine, to address anticipated revenue declines from top-selling medicines and expected patent expirations in its HIV therapies.
Separately, GSK and Germany’s CureVac have resolved a patent dispute with Pfizer and BioNTech over mRNA vaccine technology used during the COVID-19 pandemic. The settlement follows BioNTech’s agreement to acquire CureVac in an all-stock deal worth $1.25 billion to advance work on mRNA-based cancer therapies.
Under the settlement terms, CureVac and GSK will receive $740 million and single-digit percentage royalties on future U.S. sales of COVID-19 vaccines. GSK’s share amounts to $370 million, which includes $50 million to adjust terms from a 2024 licence agreement that expanded their partnership during the pandemic. If BioNTech’s acquisition of CureVac is completed, related mRNA litigation outside the United States will also be resolved, with GSK set to receive an additional $130 million and royalties on non-U.S. sales. CureVac said the acquisition remains on track under the agreed terms.
GSK stated that it continues to have separate patent cases against Pfizer and BioNTech in the United States and Europe, which are unaffected by this settlement.
In a separate development, the National Institute for Health and Care Excellence (NICE) in England has endorsed Chiesi’s Raxone for the treatment of patients aged 12 years and older with visual impairment caused by Leber’s hereditary optic neuropathy (LHON). NICE said the disease is caused by a genetic mutation that affects the normal function of cells in the eyes, often beginning with blurred vision in one or both eyes and progressing to blindness. The condition primarily affects young men and boys.
NICE estimates that about 250 people in England could be eligible for treatment with Raxone. This marks the first time NICE has endorsed a drug for this indication.
