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New Takeda Diabetes Drug Development Terminated

Takeda Pharmaceutical Company, the manufacturer of the controversial diabetes drug Actos that has been tied to an increased risk of bladder cancer, has abandoned its development on another type 2 diabetes medication due to its potential to cause liver damage.

Takeda voluntarily stopped working on its drug fasiglifam, also known as TAK-875 after trials showed it caused liver toxicity in some users. The company found that the potential risks outweighed the benefits to its fasiglifam users after carefully considering all of the research gathered. Three independent panels of experts monitored the Takeda diabetes drug in trials.

Takeda diabetes drug development terminated

Developers saw much potential in fasiglifam, which stimulates insulin sections separately from blood glucose levels. The drug showed promise because there were expectations that it would limit weight gain for users and not cause as many people to experience low blood sugar. Weight gain and low blood sugar are often side effects of oral diabetes drugs.

The voluntarily termination of the new drug comes as a major blow to the manufacturer. Early trials on fasiglifam showed that it could be its next big money maker for the manufacturer. Takeda’s profits saw a major decrease once generic versions of Actos hit the market last year. Terminating the development on this drug caused investors to take action, causing their market shares to drop 8 percent.

In addition, Takeda remains embroiled in litigation with Actos users. Approximately 3,000 Actos bladder cancer lawsuits have been filed against Takeda. They claim the manufacturer failed to properly inform the public of adverse side effects. Besides bladder cancer, a link between Actos and congestive heart failure and bone fractures also has been discovered.

The U.S. Food and Drug Administration (FDA) has issued a black box warning for Actos due to heart failure risks. This is a critical advisory issued by the FDA for prescription medications that may cause serious side effects. Despite health concerns, Actos has not been recalled in the U.S. It is no longer on the market in France and Germany due to its increased bladder cancer risks.

Background on Actos side effects and lawsuits

The first federal Actos lawsuit trial is set to begin on Jan. 27 in the U.S. District Court for the Western District of Louisiana. Jurors in the federal multidistrict litigation (MDL No. 2299) will hear the case of Terrence Allen, who claims that using Actos caused his bladder cancer.

Allen’s is the first bellwether trial in the MDL, which was created for all similar federal complaints. MDL is a procedure used to handle complex cases that include similar claims and issues of facts. The outcome of Allen’s case and other bellwether trials will be used to determine how jurors react to similar evidence and testimony. The results could prompt the defendant to negotiate Actos settlements as a way to avoid expensive jury awards in the future.

As the MDL process forward, a number of cases also have been filed in state courts across the nation. Some state trials have ended with varying results.

  1. Fierce Biotech, Takeda Suffers a Big Blow to its Diabetes Pipeline PhIII Failure of TAK-875,

  2. Takeda, Takeda Announces Termination of Fasiglifam (TAK-875) Development,