The commercial launch of Urovant Sciences’ first product, Gemtesa (vibegron), a beta 3 adrenergic receptor agonist in the US, addresses overactive bladder (OAB) symptoms by increasing bladder capacity and an unmet need for alternative, safer therapies for US patients, says GlobalData, a leading data and analytics company.

In recent years, Urovant has become established as a prominent player within OAB research and development (R&D). The company has conducted 19 clinical trials in OAB within the past five years, making it the most active sponsor in the clinical trials landscape over this time period, according to GlobalData’s clinical trials database. Urovant’s subsequent admission into the OAB market landscape is particularly timely as reliance on beta 3 adrenergic receptor agonists in place of anticholinergic agents is likely to increase in the near future.

Historically, anticholinergics have represented first-line pharmacotherapies for OAB, with this drug class accounting for 95% of OAB products marketed worldwide, according to GlobalData’s marketed products database. However, these therapies have come under increased scrutiny in recent years due to accumulating evidence that they can increase the risk of cognitive impairments and dementia.

Fiona Chisholm, Pharma Analyst at GlobalData comments: “The association of anticholinergics with cognitive decline is particularly problematic in OAB, as the prevalence of the condition steeply increases after age 60 years. Due to their advanced age, many patients may already have some form of cognitive impairment or dementia, or be more susceptible to developing these conditions.

“This highlights the need for alternative OAB therapies. As with Astellas’ beta 3 adrenergic receptor agonist Myrbetriq (mirabegron), which was launched in the US in 2012, Gemtesa is not associated with an increased risk of cognitive decline. Additionally, Gemtesa does not have a label warning for blood pressure, unlike Myrbetriq, which places Gemtesa in a strong position to steal market share from Myrbetriq, as well as anticholinergic agents.”

Despite the concerns surrounding anticholinergics, these agents are more prevalent among the late-stage pipeline* than any other drug class. According to GlobalData’s pipeline products database, there are 11 products in late-stage development for OAB worldwide, of which four are anticholinergics**.

Chisholm adds: “With anticholinergics rapidly falling out of favor, these products are unlikely to have a significant impact on the market either clinically or commercially. However, there are also several more innovative therapies in late-stage development including Urovant’s URO-902, a novel gene therapy currently in Phase II development in the US. URO-902 is administered via direct intradetrusor injections into the bladder wall, and has demonstrated statistically significant improvements in OAB symptoms compared to placebo in Phase I trials.”

*Phase II development and above

**Includes two single agent anticholinergics, one anticholinergic/beta 3 adrenergic receptor agonist combination therapy and one anticholinergic/cholinergic combination therapy