An update from Genentech on Hemlibra® post-approval data communication process and site update


The following is an excerpt from a statement from Genentech. Read the statement in its entirety here.


To the hemophilia community, At Genentech, we recognize and appreciate the ongoing conversation within the hemophilia community around the long-term efficacy and safety of Hemlibra® (emicizumab-kxwh). We understand that the subject of long-term safety for hemophilia treatments is an important topic for this community and we remain committed to listening to you and providing information that leads to informed clinical decision making and patient care.
Genentech’s first U.S. medical websites for Hemlibra were originally launched in 2018 to provide updated, verified safety information to the hemophilia community, specifically related to adverse events of interest, whether or not such events were related to Hemlibra. Today, Hemlibra is approved and available for people with hemophilia A in more than 90 countries and more than 7,200 patients around the world have been treated with Hemlibra. We now have much broader availability of information from databases and individual experiences, and the source of safety information has expanded from controlled clinical trial reporting to ongoing voluntary adverse event reporting by healthcare professionals, patients and their caregivers. That’s why we’ve launched updated versions of our medical websites and we’ve evolved our process for reporting post-approval information on Hemlibra to ensure transparency and meet the community’s expectations for information.
Read the statement in its entirety here.
 

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