Kogenate® was first approved by the U.S. Food and Drug Administration in 1993.
Bayer has announced that they are discontinuing the recombinant factor VIII product Kogenate® FS. First approved by the U.S. Food and Drug Administration in 1993, the therapy has carried multiple indications for children and adults with hemophilia A. The company cited the increasing shift in patient usage towards newer extended half-life products as a primary consideration in the decision. The emergence of novel non-factor hemophilia therapies in recent years may also be contributing to this trend away from standard half-life therapies.
The company anticipates a potential depletion of the larger vial sizes of Kogenate® FS during the fall of 2022, with supplies of the smaller vial sizes likely to be available into 2023.
Bayer has set up a hotline (1.833.40.BAYER) to field questions specific to the discontinuation. The line will be available Monday through Friday from 8:30am-8:00pm ET. More information can also be found on a company webpage.
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Source: Bayer, June 2022