Phase 3 Results Announced for Treating Severe Hemophilia A with Novel Therapy

A key clinical trial for an experimental, longer-lasting hemophilia treatment called efanesoctocog alfa (BIVV001) resulted in promising data. The developing company Sanofi and its partner Sobi just announced that they will be submitting the treatment for approval by the US Food and Drug Administration (FDA).

The novel drug is an investigational factor VIII therapy that was developed to normalize factor activity levels for the majority of the week when used as a once-weekly prophylactic treatment regimen.

Its safety, efficacy and pharmacokinetics were evaluated in the XTEND-1 Phase 3 study for patients with severe hemophilia A who had been previously treated. Patients were 12 years of age or older. Those who received the drug during the trial had less than one bleeding event over the course of a year, on average, fulfilling the primary endpoint.

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