The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old who weigh ≥40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic to be approved in the US.
Gepotidacin has also received approval from the FDA for treatment of uncomplicated urogenital gonorrhea; its use for this indication will be reviewed in a future issue.1
ACUTE uUTI — The most common bacterial cause of...
ISSUE
The FDA has approved remibrutinib (Rhapsido – Novartis), an oral Bruton's tyrosine kinase (BTK) inhibitor, for treatment of chronic spontaneous urticaria in adults who remain symptomatic despite H1-antihistamine treatment. Remibrutinib is the first oral drug to be approved in the US for this indication.
STANDARD TREATMENT — A second-generation H1-antihistamine (e.g., cetirizine, fexofenadine, loratadine) is used for initial treatment of chronic spontaneous urticaria. Patients who do not have an adequate response to FDA-approved doses of H1-antihistamines may respond to higher doses (up to 4 times the usual dose). Two subcutaneously injected drugs, the recombinant anti-IgE monoclonal antibody omalizumab (Xolair, and biosimilar) and the interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent), are FDA-approved …