FDA Grants Priority Review for GSK's Blujepa Expansion for Gonorrhea Treatment

GSK has received FDA priority review for its marketing application to expand the use of Blujepa (gepotidacin) for gonorrhea treatment. The application aims to make the antibacterial agent available to more patients with the common sexually transmitted disease.

GSK (NYSE:GSK) (LON:GSK) has received a significant boost as the U.S. Food and Drug Administration (FDA) has accepted its priority review application for Blujepa (gepotidacin), an oral antibiotic aimed at treating uncomplicated gonorrhoea. This development comes as GSK looks to expand its infectious disease product portfolio to offset expected revenue declines from top-selling medicines and looming patent expirations in its HIV portfolio.

The FDA’s priority review status indicates that the agency will expedite its decision-making process, with a potential decision expected by December. If approved, Blujepa could offer patients an oral alternative to existing injectable treatments for uncomplicated urogenital gonorrhoea, a common sexually transmitted disease.

This priority review application is part of GSK’s broader strategy to diversify its product offerings. The company has recently launched a respiratory syncytial virus vaccine and is exploring new infectious disease products to mitigate the impact of declining revenues from its core product lines. Blujepa, already approved in the U.S. under the brand name Blujepa for treating a common urinary tract infection in women and adolescent girls, now seeks to extend its therapeutic reach.

Separately, GSK and Germany’s CureVac have resolved a long-running patent dispute with Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) over mRNA vaccine technology used during the COVID-19 pandemic. Under the settlement, GSK will receive $370 million and single-digit percentage royalties on future U.S. sales of COVID-19 vaccines. If BioNTech’s acquisition of CureVac is completed, related mRNA litigation outside the U.S. will also be resolved, with GSK receiving an additional $130 million and royalties extended to non-U.S. sales.

GSK’s shares climbed 1% in London on the news of the FDA’s priority review for Blujepa, indicating investor optimism about the potential market expansion and revenue growth opportunities. The company continues to face challenges from patent expirations and declining revenues from its HIV portfolio, making the success of new infectious disease products critical for its financial health.

References:
[1] https://finance.yahoo.com/news/gsk-climbs-winning-fda-priority-081959837.html