- FDA accepts application for gepotidacin
- Positive phase-three trials
- GAK to receive $370m settlement
Pharmaceutical firm GSK (GSK) said the US FDA (Food and Drug Administration) has accepted an application to review gepotidacin, its oral antibiotic to treat sexually transmitted uncomplicated gonorrhoea in patients 12 years and older.
The shares ticked up 14p or 1% to £14.09, taking year-to-date gains to 3.5% lagging the 10% advance in the FTSE 100 index.
POSITIVE TRIAL RESULTS
The application is based on results from the late-stage EAGLE-1 clinical trial which showed superior effects compared with current standard of care treatments.
Gonorrhoea has been recognised by the World Health Organisation as a priority pathogen, and an urgent health threat by the US CDC (Centres for Disease Control and Prevention).
There were more than 600,000 cases gonorrhoea reported in the United States in 2023 according to the CDC, making it the second most reported sexually transmitted infection in the country.
There is currently no vaccine available for the prevention of the disease and the standard of care is an injectable, which may not be suitable for all patients.
In March gepotidacin was approved by the FDA under the licensing name Blujepa as an oral treatment for female adults and younger patients 12-years of age and above with a common type of urinary tract infection.
The FDA is expected to make a decision in December 2025.
COVID-19 SETTLEMENT
On Friday (8 Aug) GSK revealed it is due to receive a $370 million upfront payment plus royalties in relation to its partner CureVac’s (SCV:ETR) litigation with Pfizer (PFE:NYSE) and BioNTech (BNTX:NASDAQ) over the mRNA vaccine.
The lawsuit was filed three years ago by CureVac as it sought fair compensation for intellectual property infringements. GSK and CurVac tried but failed to develop an mRNA-based Covid vaccine but have continued to develop other products including combination vaccines.
GSK said its own patent litigations against Pfizer and BioNTech were unaffected by the settlement.
