GSK Plc (GSK) had a busy week on the regulatory front, picking up approvals and recommendations that expand the reach of several key treatments in its portfolio.
The big news came Thursday when the FDA approved a supplemental application for gepotidacin, clearing the antibiotic as an oral option for treating uncomplicated urogenital gonorrhoea. This isn't gepotidacin's first rodeo with regulators—the drug already got the green light earlier this year for treating urinary tract infections in women and adolescents. Now it's tackling another common infection, and the timing matters.
Addressing a Growing Public Health Challenge
Gonorrhoea is caused by the bacteria Neisseria gonorrhoeae and spreads through sexual contact. It's remarkably common: the CDC reported over 600,000 cases in the United States in 2023 alone, making it the second most frequently reported sexually transmitted infection in the country. That's a lot of people needing treatment.
The FDA approval covers adult and pediatric patients starting at 12 years of age who weigh at least 45 kilograms and have limited or no alternative treatment options for uncomplicated urogenital gonorrhoea caused by susceptible strains of the bacteria.
What the Clinical Data Shows
The approval leaned heavily on results from the EAGLE-1 phase 3 trial, which put gepotidacin head-to-head against the current standard of care—a combination of intramuscular ceftriaxone plus oral azithromycin. Gepotidacin proved non-inferior to that established regimen, which is regulatory speak for "it works just as well."
The safety profile looked solid too. No serious drug-related adverse events popped up in either the gepotidacin group or the comparator arm. Most side effects were mild to moderate gastrointestinal issues—not fun, but manageable and expected with oral antibiotics.
European Regulators Weigh In on RSV Vaccine
Meanwhile, across the Atlantic, GSK scored another win. On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanding the indication for Arexvy, GSK's adjuvanted recombinant respiratory syncytial virus vaccine, to cover all adults aged 18 years and older.
Right now, Arexvy is approved in Europe for adults 60 and up, plus those aged 50 to 59 who face elevated risk for RSV disease. It was actually the first RSV vaccine to get European approval for preventing lower respiratory tract disease caused by the virus in older adults. If the European Commission signs off—a decision expected in February 2026—the vaccine would become available to a much broader adult population.
More Respiratory Treatment Approvals on the Horizon
The good news didn't stop there. European regulators also issued a positive opinion for depemokimab as a treatment for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps. That's two conditions knocked out with one drug.
The CHMP also recommended approval for Nucala (mepolizumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease. The recommendation specifically covers using Nucala alongside an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist—essentially a comprehensive treatment cocktail for COPD patients who aren't getting adequate control with existing therapies.
Market Reaction
GSK shares dipped slightly on Friday, down 0.28% to $48.74, though the stock continues trading near its 52-week high of $49.31. The regulatory wins add momentum to a company that's been steadily building out its infectious disease and respiratory portfolios.