Following Actos Warning, FDA Delays Review of New Actos Combined Drug
Following Actos Warnings, FDA Delays Review of New Takeda Diabetes Drug. As is known Actos is known to cause bladder cancer in Type 2 Diabetics with long term use.
With Takeda Pharmaceuticals already facing many Actos lawsuits, the U.S. Food and Drug Administration has decided to delay its review of a new type 2 diabetes drug being developed by Takeda Pharmaceutical Company. July 2011, Takeda re-filed an application to have the drug approved by the FDA and eventually have the drug made available to the public. The new data submitted to the FDA includes information about a cardiovascular outcomes trial. The new drug would be the first in the United States to have both a thiazolidinedione and a DPP-4 inhibitor in a single pill. Currently, Aloglitin is sold in other countries and has been approved by some regulators overseas
The U.S. Food and Drug Administration has notified drug partner Takeda Pharmaceuticals that review of investigational diabetes drug alogliptin has been delayed and an approval decision is now expected by April 25, 2012. The delay also affects the fixed-dose combination drug alogliptin/pioglitazone. Regulators had previously expected to make a decision by Jan. 25, 2012.
According to a release from the company, the FDA has decided to pause the review of the investigative type 2 diabetes therapy alogliptin as well as the combination medication alogliptin/pioglitazone. Pioglitazone is the active chemical in the brand name medication Actos.
With the delay having been announced, the new Prescription Drug User Fee Act (PDUFA) action date has reportedly now been set for April 25, 2012, after the federal agency initially assigned a date of January 25, 2012, according to the release from Takeda.
Despite the delay, David Recker, senior vice president of clinical science for Takeda Global Research & Development Center in the U.S., said in a statement that the company still supported the medication's effectiveness.
"Takeda is confident in alogliptin and alogliptin/pioglitazone as potential therapeutic options for the millions of patients living with type 2 diabetes," Recker noted. "We will work closely with the FDA to determine the appropriate next steps, and are dedicated to continuing our efforts to bring these important therapies to market in the U.S."
In the release, the company disclosed that alogliptin is a highly selective dipeptidyl peptidase IV inhibitor (DPP-4i) designed to treat patients suffering from type 2 diabetes when supplemented with the proper diet and exercise.
The drug reportedly works by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which are instrumental in the regulation of blood sugar levels, the company said.
Takeda also added that it has not adjusted its fiscal outlook as a result of the delay in the drug's review, according to the release.
Still, the Japanese drugmaker has been hit hard by the recent spate of Actos lawsuits stemming from Actos warnings being handed down in the U.S. and Europe. Actos, which is also designed to treat patients with type 2 diabetes, has been linked in studies to the potential increased risk of bladder cancer, particularly among patients who have been using the medication for an extended period of time.
As a result of these Actos warnings that have been handed down by the FDA and the European Medicines Agency, Takeda now faces a number of lawsuits across the U.S., and the drugmaker recently experienced a dip in first-half operating profit.
According to Reuters, the requests from the European Medicines Agency and the FDA to add warnings to the medication's labels have had a significant impact on Actos' sales. Sales of the drug fell 13 percent in the six month-period ending September 30. This, coupled with the strong yen, has significantly dented Takeda's profits.
Doctors and patients are becoming increasingly wary of the medication as the number of Actos lawsuits pile up. Thus far, there have been lawsuits filed in states such as Illinois and Louisiana, with plaintiffs often claiming the drugmaker purposely concealed the bladder cancer side effects of the drug at the expense of patients.
While these Actos lawsuits largely center on the risk of bladder cancer, Actos has also been linked to the eye disease macular edema, which is a leading cause of blindness in older adults, according to reports.
ACTOS can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. A new study presented in June at the American Diabetes Association’s (ADA) annual meeting suggested that Actos can also lead to vision loss or blindness. Was this really new information or not? I did a little bit more research on Actos and blindness and was shocked to see that back in April 2009, the American Journal of Ophthalmology also posted a “recent study” where nearly 1,000 patients developed Diabetic Macular Edema (DME) after taking Actos. Even more shocking was a 2003 study that showed results of a retrospective study that also indicated that Actos could result in DME. According to that article, presented at the annual meeting of the American Academy of Ophthalmology, patients in that study had macular edema.
Actos is a member of a class of drugs known as thiazolidinediones, which have been linked to bladder cancer,” the US Drug Watchdog said in a released statement. “Actos side effects include increased risk of congestive heart failure, and an increased risk for bladder cancer.
Network Actos Helpline has been taking calls from people with signs of bladder cancer form Actos as well as families for Wrongful death of a loved one from bladder cancer due to Actos. Actos lawyers are filing lawsuits against TAKEDA Pharmaceuticals for Actos. In light of complications from Actos Takeda appears to be taking a very ambitious step with this new drug. If approved Ibelieve it will be a very hard sell to physicians given the warnings for Actos. If you or a loved one has complications due to Actos contact the Actos Helpline
Class Action lawyer Network Actos lawyers re filing Lawsuits on behalf of clients with complications from Actos