Urovant’s new overactive bladder (OAB) drug Gemtesa (vibegron) is approved by the FDA
… Urovant’s New Overactive Bladder Drug Gemtesa (vibegron) is FDA approved …


Urovant’s First FDA Approved Drug


John G. Baresky

The U.S. Food and Drug Administration (FDA) has approved Urovant Sciences' new drug Gemtesa (vibegron) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency and urinary frequency in adults.

The approval of Gemtesa is a strategic corporate milestone for Urovant

Gemtesa is an oral pharmaceutical agent that is produced in pill form and available by prescription only. It is a beta-3 adrenergic receptor (β3) agonist. Founded in 2016, it is Urovant’s (NASDAQ: UROV) first new drug approval.

The last new OAB drug approved by the FDA is Astellas’ (OTCMKTS: ALPMY) Myrbetriq™ (mirabegron). Myrbetriq was launched in 2012 and like Gemtesa is available only by prescription and produced in oral tablet form. The product generated approximately $850 million in sales during 2019.

Gemtesa’s market access strategy will have it competing against Myrbetriq and these other OAB products on the formularies of managed care organizations (MCOs) and pharmacy benefits managers (PBMs);

  • Botox (AbbVie)
  • Enablex (available as a generic)
  • Vesicare (available as a generic)
  • Toviaz (Pfizer)

Gemtesa will have to square off against each of these incumbents with a care and cost market access value proposition that outdistances them based on outcomes as well being somewhat cost-neutral or value-added, cost-justified to them.

Urovant is a business unit of a larger global conglomerate

Urovant is owned by Sumitomo Dainippon Pharma (DSP), a company that was formed upon the completion of a partnership between Roivant Sciences Ltd. And DSP. The Sumitovant BioPharma organization that Urovant belongs to operates 5 pharmaceutical companies; each is highly specialized:

Urovant is based in Irvine, California. Sumitovant Biopharma is located in New York City and its corporate parent Sumitomo Dainippon Pharma is headquartered in Chuo-ku, Osaka Japan. In 2019 Sumitomo Dainippon Pharma (TYO: 4506) generated over $4 billion in sales.

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