SOBI-Sanofi Partnered Hemophilia Therapy Shows Superior Bleed Protection Than Prior Prophylaxis

Swedish Orphan Biovitrum AB BIOVF and Sanofi SA SNY presented results from the XTEND-1 phase 3 study of efanesoctocog alfa (BIVV001) in previously treated hemophilia A patients.
The study met the primary efficacy endpoint, with once-weekly efanesoctocog alfa prophylaxis providing clinically meaningful bleed protection.
The median and mean annualized bleeding rates (ABR) were 0.00 and 0.71, respectively.
The study also demonstrated superior bleed protection over prior factor VIII prophylaxis with an estimated ABR reduction of 77% and a mean ABR of 0.69 compared to 2.96 on prior prophylaxis.
Once-weekly efanesoctocog alfa showed statistically significant and clinically meaningful improvements in physical health, pain intensity, and joint health when comparing week 52 and baseline measurements.
96.7% of bleeds were resolved with a single 50 IU/kg dose. Efanesoctocog alfa was well tolerated, and inhibitor development to factor VIII was not detected.
The most common treatment-emergent adverse events were headache, arthralgia, fall, and back pain.
FDA marketing application submission occurred in June 2022, and submission in the EU will follow the availability of data from the ongoing XTEND-Kids pediatric study, expected in 2023.
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