GSK Sees Positive Updates for Shingrix and Tebipenem HBr Treatments

GSK reports positive updates on Shingrix and tebipenem HBr. The European Medicines Agency has given a positive opinion for Shingrix in a prefilled syringe, simplifying the vaccine administration process. GSK and Spero Therapeutics also announced positive phase III data for tebipenem HBr, showing it is effective in treating complicated urinary tract infections. GSK plans to file for approval in the US in Q4. Shares in GSK were up 0.5% on the news.

GSK (GlaxoSmithKline) has announced positive developments for two of its key products. The European Medicines Agency (EMA) has given a positive opinion for Shingrix in a prefilled syringe, simplifying the vaccine administration process. Additionally, GSK and Spero Therapeutics have reported positive phase III data for tebipenem HBr, demonstrating its effectiveness in treating complicated urinary tract infections (UTIs).

The prefilled syringe presentation of Shingrix (recombinant zoster vaccine [RZV]) has been approved by the FDA for the prevention of shingles (herpes zoster), eliminating the need for healthcare professionals to reconstitute separate vials prior to administration, according to Patient Care Online.

The positive opinion from the EMA further supports GSK's commitment to enhancing adult immunization rates. The prefilled syringe presentation is currently undergoing regulatory review by the EMA, with filing acceptance received in January 2025. GSK has indicated it is exploring submission of this presentation to other markets as part of its commitment to increasing adult immunization rates, as noted by Patient Care Online.

In parallel, GSK and Spero Therapeutics have reported positive phase III data for tebipenem HBr, a novel antibiotic aimed at treating complicated UTIs. The data show that tebipenem HBr is effective in treating these infections, which can be challenging to treat with existing therapies. GSK plans to file for approval in the US in Q4 2025, according to Quiver Quant.

Shares in GSK were up 0.5% on the news, reflecting investor confidence in the company's pipeline and the positive regulatory outlook for both Shingrix and tebipenem HBr.