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Astellas Bladder Treatment Wins U.S. Approval for Sale

Astellas Pharma Inc. won approval for its overactive bladder treatment aimed at an estimated 33 million Americans who suffer from the condition.

The Food and Drug Administration cleared the drug, mirabegron, to treat the need to frequently or involuntarily urinate, the agency said yesterday in a statement. The drug enhances bladder storage without affecting patients’ ability to urinate like others on the market. Tokyo-based Astellas will market the treatment as Myrbetriq, the FDA said.

Sales of the treatment would help Astellas, Japan’s third-largest drugmaker, buffer a decline in revenue when its Vesicare bladder-control medicine, which generated $1 billion in sales in the last fiscal year, loses patent protection in November 2018.

“Today’s approval provides a new treatment option for patients with this debilitating condition,” Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Current treatments include Pfizer Inc.’s Detrol, Warner Chilcott Plc’s Enablex and Astellas’s Vesicare. Astellas expects Myrbetriq to be supplied to pharmacies in the fourth quarter of 2012, the company said in a statement.

Side Effects

FDA staff expressed concern in an April 3 report that the treatment increased heart rates and blood pressure and was associated with hypersensitivity reactions ranging from painful rash to anemia. The drug also was linked to tests revealing potential liver disease, a small number of urinary tract infections and malignant tumors, FDA staff wrote. The reason the medicine may lead to tumor formation is unknown, staff said.

Myrbetriq isn’t recommended for use in those with severe uncontrolled high blood pressure, end-stage kidney disease or severe liver impairment, the FDA said.

Clinical trials showed 25 milligram and 50 milligram doses of Myrbetriq reduced the number of times patients urinated and had wetting accidents in a 24-hour period, according to the FDA statement. Patients on the 50-milligram pill also expelled more urine, demonstrating the drug’s ability to improve the storage capacity of the bladder, the agency said.

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