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Idelvion approved by USFDA

10-Mar-2016

The United States Food and Drug Administration has approved Idelvion for treatment of hemophilia B. The drug has been developed using the recombinant DNA technology linking Factor IX to albumin, and it is to be manufactured by CSL Behring.

 

Idelvion has been tested in 90 adults and pediatric hemophilia B patients. In the clinical trials, intravenous administration of Idelvion has been shown to provide long-lasting benefit for 7-14-day period and prevented blood loss in these patients.

 

Among the trial subjects, 94% of bleeding events were controlled after single dose of Idelvion, while 99% of events were effectively treated with one or two more doses. Due to its long-lasting action, Idelvion can be administered fortnightly.

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