Sumitomo gains FDA approval of Gemtesa for OAB
The US subsidiary of Japan’s Sumitomo Pharma (TYO: 4506) announced that the US Food and Drug Administration (FDA) has approved Gemtesa (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH).
According to Sumitomo Pharma America (SMPA), this approval marks Gemtesa as the first and only β3 agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the USA.
The global overactive bladder treatment market size was valued at $2.4 billion in 2021 and is projected to reach $3.5 billion by 2031.
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