New Hemophilia A Treatment Approved by FDA
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved Bayer’s Jivi (BAY94-9027) as a preventive treatment for bleeding in hemophilia A. Treatment was based on two years of Phase II/III clinical trials that showed the regular intravenous treatment protected patients from bleeding for a median of nearly two years. In the trial, 141 patients were split into preventive and on-demand groups between April 2012 and June 2014. Results showed Jivi seemed effective as an on-demand response to bleeding, resolving 91 percent of severe bleedings with one or two treatments.
References
FDA Approves New Hemophilia A Treatment. FDAnews Drug Daily Bulletin, Sept. 5, 2018. Accessed at www.fdanews.com/articles/188254-fda-approvesnew-hemophilia-a-treatment?utm_campaign=Drug%20Daily%20Bulletin&utm_ source=hs_email&utm_medium=email&utm_content=65677406&_hsenc= p2ANqtz-9UcP3uxMPYAnLQiR6JXo8Q4ZizbKJ-DGWSsQjQJf2THXd0x26n Dv4CPUwm_ykxFHDhHz2Yf4KKZPlMweSpZ5f-46_Y8Q&_hsmi=65677406.
