The Food and Drug Administration questioned Tuesday whether it should approve an expanded use for a Pfizer Inc. (PFE) drug that's designed to prevent blood clots.
Pfizer is proposing to expand the use of its drug, Fragmin, to prevent a condition known as venous thromboembolism in cancer patients. Venous thromboembolism is caused when a blood clot forms in the legs and then travels to the lungs. The condition can be fatal.
An FDA panel is set to consider Fragmin for use in cancer patients Wednesday. The agency posted its review of the drug on its Web site Tuesday as is customary the day before panel meetings.
Fragmin has been on the the U.S. market since 1994 and is approved for short-term use in patients undergoing certain types of abdominal and hip replacement surgery. The drug is also approved for long-term use in patients with certain heart conditions along with aspirin therapy.
Pfizer is asking the FDA to approve Fragmin for use in cancer patients based on a clinical trial involving 676 patients who previously had a blood clot on Fragmin to patients using other drugs such as warfarin in order to prevent blood clots. Many cancer patients have a high risk of developing venous thromboembolism.
Overall, the study found that patients in the Fragmin group had a 52% reduction in the risk of having a recurrence of venous thromboembolism compared to those receiving other anti-clotting therapy. The study, known as CLOT, was published in 2003 in the New England Journal of Medicine.
In its review, the FDA agreed that the study results showed Fragmin reduced recurrence of venous thromboembolism. However, the agency said "essentially all the treatment benefit was evidenced during the first month of therapy." The agency also noted that about 40% of patients in the study died of mostly cancer-related causes before the six-month study was completed, making study findings hard to interpret. The FDA also said the number of patients experiencing bleeding and other complications was "numerically" higher in the Fragmin group and said liver enzyme elevations - which could indicate liver damage - were "noted among more Fragmin patients."
The agency also said that Fragmin isn't currently approved to treat venous thromboembolism in any population and that approving the drug for that use in cancer patients might have "implications for similar uses among patients without cancer - a situation in which the CLOT study findings may not fully predict the risks and benefits of the treatment usage."
Pfizer said that there's currently no approved medication for the treatment of venous thromboembolism in cancer patients in the U.S. and that using Fragmin reduced the risk of having the problem recur. The company said Fragmin "has a favorable risk/benefit profile" for use in cancer patients.
Global Drug Pipeline
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