British pharmaceutical company GSK announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted its application for priority review of gepotidacin, an oral antibiotic intended to treat uncomplicated gonorrhea, a common sexually transmitted infection. The FDA’s decision on this new indication is expected by December.
Gepotidacin is already approved in the United States under the brand name Blujepa for treating urinary tract infections (UTIs) in women and adolescent girls. If the new approval is granted, it would offer patients a convenient oral alternative to the current standard of care, which primarily involves injectable antibiotics.
GSK is placing significant emphasis on developing treatments for infectious diseases to balance revenue declines from patent expirations on its leading HIV drugs. This focus includes the recent launch of its respiratory syncytial virus (RSV) vaccine, which is also expected to contribute to the company’s future growth.
By pursuing innovative therapies like gepotidacin, GSK aims to strengthen its position in the competitive pharmaceutical market while addressing urgent public health needs such as antibiotic resistance and limited treatment options for gonorrhea.