Shots:
- The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026
- Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in hospitalized pts with cUTI, incl. pyelonephritis. At the test-of-cure visit, the ORR was 58.5% (261/446) vs 60.2% (291/483)
- In 2022, GSK & Spero entered into an exclusive licence agreement for Utebzi, granting GSK a licence to develop & commercialise it in all countries except Japan & certain other Asian countries
Ref: GSK | Image: GSK & Spero Therapeutics | Press Release
Related News: GSK to Acquire Nuvalent for ~$10.6B
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