PHARMACY

FDA calls for Takeda to stop high-dose cholesterol drug trials

BY Drew Buono

WASHINGTON The Food and Drug Administration has recommended that Takeda Pharmaceuticals stop conducting its high-dose trials of TAK-475, a cholesterol drug, due to concerns over possible liver damage.

The drug had been revealed to increase transaminase elevations, which is a warning signal of possible liver damage, in high and also in comparable low-level doses. This has made the FDA also request additional clinical data before the company submits an application for the drug.

The additional clinical studies will set back Takeda’s plans to submit an application for TAK-475 by the end of June 2008, the company said, adding it is discussing future development plans with the FDA and European and Japanese regulatory authorities.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Heritage launches its formulation of the generic hydrochlorothiazide

BY Drew Buono

EDISON, N.J. Heritage Pharmaceuticals has launched its new drug hydrochlorothiazide.

The drug is used as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. The drug is also used in the management of hypertension.

The drug is available in 25 and 50 mg tablets in 100 and 1000 count bottles. Total annual market sales for Hydrochlorothiazide tablets in the U.S. were $30.8 million, according to March 2007 IMS data.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Bayer pulls clotting drug from worldwide market

BY Allison Cerra

FRANKFURT, Germany Bayer has stopped worldwide sales of its anti-bleeding drug after a clinical study revealed the drug poses a higher risk of death.

Trasylol (aprotinin), designed to stem blood loss and enable patients receiving heart bypass surgery to avoid the use of transfusions, was tested in a Canadian clinical study last month. Preliminary results from that trial also suggested Trasylol increased the risk of death when compared with the other drugs.

Additional tests, which would have compared the safety and effectiveness of Trasylol with two others was halted after the initial results surfaced.

Leverkusen-based Bayer said Monday that it made the decision after discussions with the Food and Drug Administration, the German Federal Institute for Drugs and Medicine Products along with Health Canada.

Last week, the FDA said that evidence suggests Trasylol increased the risk of death compared with other drugs, and that the drug was blocking enzymes which dissolve blood clots, instead of aiding them. The agency began reevaluating the drug’s safety after the January 2006 publication of two studies that linked the drug’s use to serious side effects, including kidney problems, heart attacks and strokes.

The FDA approved the drug in 1993 to prevent the loss of blood and thwart the need for blood transfusions in surgeries to bypass clogged coronary arteries.

More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a “regrettable human error.”

Bayer said it wanted to review the results from the Canadian trials before moving forward.

“Once the complete … dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” the company said in a statement. “At that time the temporary marketing suspension will be reevaluated.”

Shares of Bayer gained nearly 1.6 percent to €57.57 ($83.36) in Frankfurt.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?