Reuters: Regulatory News: UPDATE 2-FDA staff focus on safety of Astellas bladder drug

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

UPDATE 2-FDA staff focus on safety of Astellas bladder drug Apr 3rd 2012, 13:42 Tue Apr 3, 2012 9:42am EDT * FDA staff says drug works for overactive bladder * Key issues tied to heart, liver safety * Advisory panel to vote on drug Thursday By Anna Yukhananov WASHINGTON, April 3 (Reuters) - U.S. drugs reviewers said Astellas Pharma Inc's treatment for an overactive bladder worked, but they raised concerns about liver and heart safety issues. The U.S. Food and Drug Administration staff said the once-daily tablet, called mirabegron, worked to reduce frequent urination and the inability to control it, according to documents released online on Tuesday. But the pill, already approved in Japan, was also tied to a higher rate of neoplasms, or tumors, urinary tract problems and hypersensitivity reactions, according to the FDA staff. "The special safety concerns, especially the increases in blood pressure and pulse ... require additional consideration relevant to their potential negative public health effects," staff said in the documents. The staff review comes ahead of a vote Thursday by an FDA advisory panel on whether to recommend approval of the drug. The FDA will make a final decision by June 29, taking into account the panel's recommendation. Overactive bladder, caused by uncontrollable contractions of the bladder, affects about 12 percent of adults in Europe and the United States, and 30 percent to 40 percent of those 75 years and older, Astellas said. Mirabegron, the first drug in its class, works by activating a protein receptor - a beta-3 adrenoceptor - in bladder muscles that help the bladder fill and store urine. The FDA staff said most of the safety data for mirabegron appeared "reasonable," except for the heart and liver issues. However, there were some discrepancies in how much the drug increased blood pressure and heart rate in different clinical trials. The FDA reviewers also said people taking the drug during clinical trials had a higher rate of tumors compared to people on a placebo, but it was unclear why this happened. Astellas, Japan's second-largest drugmaker, said mirabegron can provide another option to patients beyond current treatments for overactive bladder. Current treatments include the Astellas drug Vesicare, one of the company's biggest products, which garnered global sales of 86.7 billion yen ($1.1 billion) in 2010. With mirabegron, Astellas is hoping to cement its position in the overactive bladder market, the company said. Mirabegron is approved in Japan under the trade name Betanis. Global sales of Vesicare and mirabegron should total over 155 billion yen ($1.9 billion) in the fiscal year ending in March 2015, the company said in its annual report. Link this Share this Digg this Email Reprints

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions