Roche has announced that the U.S.A Food and Drug Administration (FDA) has approved Hemlibra (emicizumab-kxwh) for the treatment of hemophilia A with inhibitors. This approval is for a very specific indication, and it is the result of FDA fast-track approval. The WFH understands that regulatory agencies in other regions are also considering fast-tracking the approval of Hemlibra.
Note: the following warning was given regarding the use of Hemlibra: “The labeling for Hemlibra contains a boxed warning to alert healthcare professionals and patients that severe blood clots (thrombotic microangiopathy and thromboembolism) have been observed in patients who were also given a rescue treatment (activated prothrombin complex concentrate) to treat bleeds for 24 hours or more while taking Hemlibra.”
To read the press release published by Roche (English), please click here.