Myrbetriq Receives FDA Approval

The US Food and Drug Administration has confirmed that it has approved Japanese drug maker Astellas Pharma’s Myrbetriq pill for treating overactive bladder in adults. The approval was along the expected lines after an advisory committee voted that the drug’s benefits in treating overactive bladder outweighed the risk of side effects which includes heart and liver problems. The decision came following results of clinical trials which showed that 50-milligram dose of the drug reduced the number of trips to the bathroom by four times over a period of 7 days when compared to placebo.

Stating that overactive bladder was an uncomfortable and potentially serious condition, Dr Victoria Kusiak, deputy director in an FDA office for drug evaluation, said, “An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting, and potentially serious. Today's approval provides a new treatment option for patients with this debilitating condition.”



Source-Medindia