Regulatory Focus™ > News Articles > FDA Approves Astellas' Bladder Control Drug

FDA Approves Astellas' Bladder Control Drug

Posted 29 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) on 28 June approved Astellas Pharma Global Development's overactive bladder treatment drug Myrbetriq (mirabegron).

The drug is used at the 25mg and 50mg dosage levels to reduce the severity of overactive bladder, which FDA explained is a condition in which the bladder muscle is uncontrolled. "Today's approval provides a new treatment option for patients with this debilitating condition," wrote Victoria Kusiak, deputy director of FDA's Office of Drug Evaluation III.

The drug took ten months to approve, having been received by FDA on 28 August 2011. Under the terms of Myrbetriq's  approval, Astellas will need to conduct a total of four postmarketing studies.

The first two postmarketing studies will test the safety, tolerability and efficacy of Myrbetriq when used on patients between five and eighteen years of age.

Astellas will also need to conduct two postmarketing studies in adult populations, both of which must be completed by 2019. The first study will assess patients in a long-term evaluation to assess their susceptibility to cardiovascular events, which was noted as a side-effect in FDA's approval letter. The second study will assess the product's carcinogenicity, which was also identified as a possible risk by FDA.

The drug had earlier been narrowly recommended by an FDA advisory committee in a 7-4 vote despite being seen as offering only a "marginal" benefit over a placebo.

Read more:

FDA- FDA approves Myrbetriq for overactive bladder

Myrbetriq - FDA Approval Letter

Myrbetriq - Approved Label

Regulatory Focus newsletters

All the biggest regulatory news and happenings.