FDA Approves New Hemophilia A Treatment
The FDA approved Bayer’s Jivi as a preventative treatment for hemophilia A, the agency announced Friday.
Jivi, the brand name for the treatment BAY94-9027, spent two years in a Phase 2/3 clinical trials and showed the regular IV treatment protected patients from bleeding for a median of nearly two years.
The trial enrolled 141 patients between April 2012 and June 2014 and split them into preventative groups or on-demand groups. In 2014, researchers reported that Jivi seemed effective as an on-demand response to bleeding, resolving 91 percent of severe bleedings with one or two treatments.
Hemophilia A is a genetic disorder that affects mostly boys and men. It occurs in about 1 in every 5,000 live, male births, according the National Hemophilia Foundation.