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TAKEDA FAILS TO GET FDA APPROVAL FOR ACTOS FOLLOW-UP

TAKEDA FAILS TO GET FDA APPROVAL FOR ACTOS FOLLOW-UP

The giant drugmaker Takeda Pharmaceutical Co. has failed to secure federal approval to market its follow-up to the diabetes drug Actos. Takeda sought to sell its diabetes drug, called alogliptin, in the U.S., but the Food and Drug Administration has requested more information on the cardiovascular risks associated with this potentially dangerous pharmaceutical.

Federal regulators may be more cautious in approving Takeda's newest diabetes drug because of the fallout from the drugmaker's last product, Actos, which has been shown to drastically increase the likelihood that a patient will develop cardiovascular issues.

Actos was a blockbuster pharmaceutical for Takeda because it was thought to avoid the cardiovascular risks associated with Avandia, a competing drug. Subsequent studies uncovered that Actos also increased the risk of several potentially life-threatening cardiovascular conditions such as heart disease, heart failure and heart attacks.

Takeda recently came under further scrutiny after a wave of Actos users began developing liver cancer. It appears that the diabetes drug also significantly increases the risk of kidney cancer in longtime users and it is unclear whether Actos is safer than alternative treatments, given the severe side effects associated with this drug.

The drug alogliptin has been approved in Takeda's home country of Japan and is sold under the name Nesina, but it is unclear whether the drug will ultimately be approved by the FDA for release in the United States.

Source: Bloomberg, "Takeda's Successor Drug to Actos Fails to Win Approval," Kanoko Matsuyama, April 26, 2012

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