Urovant Sciences is committed to developing and commercializing innovative therapies designed to improve the quality of life of people with urological conditions and diseases.
Our approach is defined by our passion for science and medicine, combined with our mission to advance urological care. We are committed to delivering meaningful products with significant benefits to our patients, their caregivers and their treating healthcare providers. We maintain a quality and compliance-focused culture that enables and ensures employees follow all applicable regulatory requirements to safeguard our patients and the quality of our products.
OAB is a condition characterized by the sudden urge to urinate that is difficult to control with or without accidental urinary leakage, and usually with increased frequency of urination. Accidental urinary leakage resulting from urgency is referred to as urge urinary incontinence. More than 30 million Americans over the age of 40 live with the bothersome symptoms of OAB.
There are approximately 40 million men between the ages of 50 and 80 in the U.S. with BPH, with about 4.5 million currently being treated for their symptoms. BPH is characterized by changes in the prostate affecting the bladder outlet, which can prevent normal urine flow. It is progressive with age, and many patients also have concomitant OAB, which is not well-managed by current therapies. Approximately 50% of BPH patients also suffer from OAB. A majority of men with BPH and OAB are not treated for their OAB symptoms.
At Urovant Sciences, we are committed to high standards of product safety, efficacy, and regulatory compliance, including adherence to post-market requirements for reporting adverse events, product complaints and other reportable events.
We are committed to ensuring company-wide compliance with post-market requirements for reporting adverse events, product complaints and other reportable events. Urovant Sciences’ Pharmacovigilance and Product Complaint policy establishes that all employees and agents are part of the Pharmacovigilance System (PV System) and that the PV System performance depends on all stakeholders being aware of and contributing to pharmacovigilance activities.
Pharmacovigilance is a company-wide, global concept, spanning the whole lifecycle of a product. Although some functions will be more involved than others in the PV System-related deliverables, every individual in the organization needs to learn about and understand pharmacovigilance-relevant information relating to the products for which the company holds a marketing authorization.