Astellas Pharma is one step closer to building its blockbuster business in overactive bladder meds. An FDA panel has backed approval of the Japanese drugmaker's treatment mirabegron, voting 7-4 that the benefits outweigh the safety risks, the company said Thursday.
Tokyo-based Astellas hopes the FDA takes the panel's recommendation, as the agency often does, and provides the company with its second drug approved for overactive bladder in the U.S. Some 42 million Americans have the condition, which causes them to need to urinate frequently. It is most common in elderly patients. The agency is expected to take action on its review of mirabegron by June 29.
However, the future success of the drug, which is already approved in Japan, remains uncertain in the U.S. market. The med poses safety risks to the heart and liver, and some panelists expressed concern over the treatment's marginal benefits, according to a Reuters report. Taken orally once a day, mirabegron targets B3-receptors in bladder muscles to prevent the uncontrolled contractions that cause frequent trips to the bathroom.
Astellas already markets the blockbuster overactive bladder drug Vesicare, but that med faces loss of patent protection in three years. Mirabegron could ease the pain of declining revenue from Vesicare, Bloomberg reports. Reuters says Astellas is aiming to reach $1.9 billion in sales from both Vesicare and mirabegron by the end of its fiscal year that ends in March 2015.