GSK reports positive trial data for oral cUTI treatment, secures EU backing for simplified shingles vaccine

(Sharecast News) - Drugmaker GSK made two key updates on Monday, with positive phase III trial results for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections, and a favourable regulatory opinion for a new prefilled syringe format of its shingles vaccine, Shingrix. GSK and partner Spero Therapeutics said the pivotal PIVOT-PO trial had demonstrated non-inferiority of oral tebipenem HBr versus intravenous imipenem-cilastatin in hospitalised patients with cUTIs, including pyelonephritis.

The study, halted early for efficacy, showed a 58.5% overall success rate for tebipenem HBr compared to 60.2% for the IV comparator. Adverse events were mild or moderate, with diarrhoea and headache the most common.

Separately, GSK said the European Medicines Agency's CHMP had issued a positive opinion supporting approval of Shingrix in a prefilled syringe format. The new presentation, expected to be approved by the European Commission in December, will eliminate the need to reconstitute two separate vials, streamlining administration for healthcare professionals.

Shingrix has already been approved in the EU for the prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 and over, and in those aged 18 and above at increased risk. GSK said the CHMP opinion was based on data confirming technical comparability between the new format and the existing two-vial presentation.

Reporting by Iain Gilbert at Sharecast.com