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Follow-up to Actos, Nesina, Delayed by FDA
By Scott Hardy
The FDA just dealt what could be a major blow to Takeda Pharmaceutical by delaying their approval of Nesina (alogliptin), their follow-up to bladder cancer plagued type 2 diabetes drug Actos. Takeda Pharmaceuticals is pushing heavily for the new drug because Actos will lose its patent protection in four months. Once that happens we will see generic versions of Actos be released by rival pharmaceutical drug companies. That could, and likely will, subtract billions of dollars in revenue from Takeda Pharmaceuticals bottom line. They need a new drug that will treat diabetes, is protected by a new patent, and will be charged at a similar fee structure as Actos. The release of the new drug will also give patients who are avoiding Actos due to the risk of bladder cancer, over have already contracted bladder cancer after using Actos, a new venue to use for treatment of diabetes.
The FDA is also concerned that use of Nesina may result in an increased risk of cardiovascular injuries and they want more studies to be conducted or released which emphasize the safety of the drug. This is the second time that the FDA has rejected Takeda Pharmaceuticals application for Nesina. Some in the federal government are concerned about approving Nesina after studies have shown that the drug it is effectively replacing, Actos, increases the risk of bladder cancer in long term users by at least 40%. In addition, hundreds of Actos bladder cancer lawsuits, and at least one Actos bladder cancer class action lawsuit, have been filed in US courts which may also be a factor leading to the FDA's high level of scrutiny of the new drug.
Takeda Pharmaceuticals insists that the delay won't be a problem and that they can provide proof of the safety and efficacy of Nesina by supplying data from information collected outside of the U.S. and from patient studies currently underway. Nesina (alogliptin) is already in use in other countries, including Takeda Pharmaceuticals home country of Japan, and they are confident that their eventual response to the FDA will fulfill their needs get their replacement for Actos on American shelves.
Attorneys around the US are already researching Nesina's use and side effects in other countries to see if it has similar potentially deadly side effects like Actos. If you would like more information about filing an Actos bladder cancer class action lawsuit or an Actos bladder tumor personal injury lawsuit just go to the Actos Bladder Cancer Class Action Lawsuit Investigation page. There you can submit your information to attorneys who are actively investigating all claims regarding tumors, heart attacks and other problems which may be attributed to Actos. These attorneys will also likely be investigating any severe side effects which may be a result of Nesina after it is released in the US.
Updated April 30th, 2012
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