FDA approves Astellas’ leaky bladder drug
pharmafile | July 3, 2012 | News story | Sales and Marketing | Astellas, FDA, Myrbetriq, bladder, urology
The FDA has approved Astellas’ new overactive bladder disorder drug Myrbetriq.
Myrbetriq (mirabegron), the first drug in its class, works by activating a protein receptor in bladder muscles that relaxes them and helps the bladder fill and store urine. The pill was approved in Japan last July.
The drug will be a successor to Astellas’ established overactive bladder drug Vesicare (solifenacin), which brought in just over $1 billion last year.
“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, deputy director of the office of drug evaluation at the FDA.
“[The drug’s] approval provides a new treatment option for patients with this debilitating condition.”
Myrbetriq’s safety and efficacy were demonstrated in three placebo-controlled trials, which tested 4,116 patients with overactive bladder disorder.
Results showed that Myrbetriq 25mg and 50mg effectively reduced the number of times a patient urinated, and the number of times a patient had wetting accidents during a 24-hour period.
Patients taking Myrbetriq (50mg) also expelled a greater amount of urine, demonstrating the drug’s effectiveness in improving the storage capacity of the bladder.
The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased to 50mg once-daily, Astellas says.
“OAB impacts each individual differently so it is important to have a variety of treatment options available,” said Victor Nitti, professor of Urology and Ob/Gyn at the Department of Urology and director of female pelvic medicine and reconstructive surgery NYU Langone Medical Center.
“With Myrbetriq, US physicians now have a new therapy option to offer many Americans living with overactive bladder.”
Ben Adams
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