Hemlibra Patent Dispute Spills Over Into Patient Community
After Shire seeks preliminary injunction to carve-out certain patients from obtaining the hemophilia treatment, Genentech issues open letter saying patients should not be put in the middle of a patent dispute.
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Shire explains why it is seeking preliminary injunction against Genentech; National Hemophilia Foundation and Hemophilia Federation of America decline to take position on dispute.
Hemophilia A drug's labeling reflects data on physical function improvement because FDA deemed that portion of the Haem-A-QoL instrument fit for purpose, while other questions were viewed as insensitive to change or irrelevant. Review documents suggest agency was unimpressed with results from a health status instrument frequently used in economic analyses.
Hemophilia patient advocate expressed concerns to FDA about ability of hemophilia treatment centers to educate patients about thrombotic microangiopathy and thromboembolic events, unexpected but serious cases of which were seen in the clinical program.