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FDA approves new use of drug in patients with hemophilia A
The agency also warned manufacturer of ovarian cancer screening test that the product has not received marketing clearance.
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Last week, the FDA approved the new use of an antihemophilic factor (recombinant), allowing the drug to be used in reducing the frequency of bleeding episodes and in preventing joint damage in children with hemophilia A.
Kogenate FS (Bayer Healthcare), a genetically engineered version of factor VIII, was originally licensed in the United States in 1993 for surgical use and the prevention or control of bleeding episodes, according to a press release.
The researchers conducted a clinical trial to investigate the use of the drug in children with hemophilia A. They enrolled 65 boys aged younger than 30 months who had severe hemophilia A and normal joints. During five years, the patients received either one daily dose of Kogenate FS or three doses at the time of a bleeding episode.
Boys who received the drug daily experienced a sixfold lower rate of joint damage during a bleeding episode and an eightfold lower rate of bleeding compared with boys who only received the drug at the time of the bleeding episode.
Warning letter issued for screening test
On Sept. 29, the FDA issued a warning letter to LabCorp, indicating that the company does not have market clearance or FDA approval for the marketing of Ovasure, an ovarian cancer screening test.
In the warning letter, the FDA said it has determined that Ovasure has been designed, developed and validated by researchers at Yale University and not LabCorp. Yale University researchers also appeared to have developed the materials and instructions for use. Therefore, Ovasure is out of the scope of lab-developed tests that the FDA typically exempts from obtaining approval — that is, tests that are developed and performed by a single lab.
LabCorp announced the availability of Ovasure in a June 23 press release. According to the press release, Ovasure uses six biomarkers to distinguish between disease-free women and women with ovarian cancer. The company reported that recent study results revealed that the test had 99.4% specificity and 95.3% sensitivity.