New Data Reinforce Favorable Safety, Efficacy Of Roche's Hemlibra For Hemophilia A

Roche Holdings AG RHHBY announced results from the primary analysis of the phase 3 HAVEN 6 study of Hemlibra (emicizumab) in people with moderate or mild hemophilia A.
The data showed that Hemlibra demonstrated a favorable safety profile and effective bleed control in patients without factor VIII inhibitors.
The primary analysis included data from 72 participants who warranted prophylaxis.
The data show that Hemlibra maintained low treated bleed rates across the study period, with 66.7% of participants experiencing no bleeds that required treatment at 55.6 weeks median follow-up.
81.9% experienced no spontaneous bleeds that required treatment, and 88.9% experienced no joint bleeds that required treatment.
Annualized bleed rates remained low throughout the evaluation period at 0.9.
Local injection site reactions were the most common adverse event related to treatment.
One participant experienced a grade one thromboembolic event unrelated to Hemlibra.
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