BioMarin’s Roctavian Receives the US FDA’s Approval for the Treatment of Severe Hemophilia A
Shots:
- The approval was based on the P-III (GENEr8-1) study evaluating Roctavian in patients (n=134) with severe hemophilia A. For 112 patients, baseline ABR data were collected during 6mos. on FVIII prophylaxis before receiving Roctavian & for 22 patients, baseline ABR was collected retrospectively
- The results showed that in 112 patients, a mean ABR reduction of 52% was reported after receiving Roctavian by the end of follow-up (2.6 bleeds/year) vs baseline ABR while receiving routine FVIII prophylaxis (5.4 bleeds/year) & rate of spontaneous bleeds & joint bleeds was also reduced with Roctavian (0.5 & 0.6 vs 2.3 &3.1 bleeds/year)
- BioMarin expects to continue to monitor the long-term effects of the treatment with a follow-up of 15yrs.
Ref: PR Newswire | Image: BioMarin
Related News:- BioMarin’s Roctavian (valoctocogene roxaparvovec) Receives EC’s Conditional Marketing Authorization for Severe Hemophilia A
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