The recommended daily dose is a 75mg film-coated tablet.
The approval is backed by data from the Phase III EMPOWUR clinical trial, which assessed it for 12 weeks in 1,515 OAB patients.
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Participants received a daily dose of either placebo, vibegron 75mg or an active control.
Vibegron significantly reduced daily urination and incontinence episodes versus placebo, with improvements observed within two weeks and sustained over the treatment period.
Capivasertib, an AKT inhibitor, impedes cancer cell proliferation and is administered orally alongside fulvestrant, a hormonal therapy.
The approval was supported by a clinical trial involving 708 patients, with a subset of 289 patients exhibiting the targeted genetic mutations.
In clinical studies, capivasertib-treated individuals had an average of 7.3 months during which their cancer did not progress, compared to 3.1 months for placebo-treated patients.
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