FDA Partially Rescinds Indications for BeneFIX and Ixinity

FDA Partially Rescinds Indications for BeneFIX and Ixinity

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FDA Partially Rescinds Indications for BeneFIX and Ixinity

Owing to conflicting market exclusivity rights, the U.S. Food and Drug Administration (FDA) has partially rescinded its decision to approve BeneFIX and Ixinity for additional indications both therapies received last year for the treatment of hemophilia B, according to the National Hemophilia Foundation. Pfizer’s BeneFIX and Aptevo Therapeutics’ Ixinity are man-made (recombinant) forms of factor IX (FIX), the blood-clotting protein that is missing or defective in patients with hemophilia B. Both are designed to control or…

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