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GSK PLC on Tuesday announced a double dose of good news regarding shingles drug, Shingrix, and urinary tract infection treatment, tebipenem HBr. The London-based pharmaceuticals company said the European Medicine Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion to support the approval Shingrix in a prefilled syringe. Currently, the vaccine presentation consists of two vials, a lyophilised powder antigen and a liquid adjuvant, which are combined prior to administration. After approval by the European Commission, expected in December, the new prefilled syringe will remove the need to reconstitute separate vials, simplifying the vaccine administration process. In addition, GSK and Nasdaq-listed Spero Therapeutics Inc announced positive Pivot-PO phase III data which showed tebipenem HBr’s potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections. The firms said the primary endpoint was met, demonstrating non-inferiority of oral tebipenem HBr compared to intravenous treatment. ‘These ground-breaking data show for the first time that cUTIs, including pyelonephritis, can be treated with an oral carbapenem antibiotic as effectively as with an intravenous one,’ said GSK Chief Scientific Officer Tony Wood. GSK said it plans to work with US regulatory authorities to include the data as part of a filing in the fourth quarter. If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the US for patients who suffer from cUTIs. Tebipenem pivoxil is being developed in collaboration with Massachusetts, US-based Spero Therapeutics. In September 2022, GSK entered into an exclusive license agreement with Spero for the development and commercialisation of tebipenem HBr in all markets, except certain Asian territories. Shares in GSK were up 0.5% at 1,641.00 pence each in London on Tuesday morning. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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