MHRA approves Obgemsa and Truqap

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday announced it has approved two new medicines for use in Great Britain.

First up, the Agency cleared Obgemsa (vibegron), from privately-held French drugmaker Pierre Fabre, to treat the symptoms of overactive bladder (OAB) syndrome in adults. Symptoms may include a sudden need to empty the bladder (urgency), urinating more frequently (urinary frequency), and urinary incontinence.

This approval is supported by evidence from a Phase III clinical trial. The EMPOWUR study was used to evaluate vibegron over a period of 12 weeks in 1,515 patients with OAB syndrome and demonstrated symptoms of urgency and urinary frequency, with or without urge urinary incontinence. Patients received a single daily dose of placebo (n=540), vibegron 75 mg (n=545), or active control (n=430).