HemoRel-A safe in severe Hemophilia A Patients

A recent study published in JAPI tried to evaluate efficacy for on-demand treatment of acute bleeding events, pharmacokinetics, safety, and tolerability of HemoRel-A in severe hemophilia A.

A total of 44 male subjects with severe hemophilia A with an annualized bleed rate of 12 while on-demand treatment with factor 8 were enrolled in the study and received HemoRel-A for bleed treatment. The efficacy of HemoRel-Awas evaluated based on a four-point scale (excellent, good, moderate, or none). The six-point pharmacokinetic assessment was performed following a single dose of 50 IU/kg in 12 subjects after a 7-day wash-out period. Safety evaluations were performed at each visit and inhibitor testing was performed in all patients at screening and end of the study.

Forty-four male subjects received at least a single dose of the study medication and were included in the intent-to-treat analysis and safety outcome. The results showed that HemoRel-A efficacy was rated as excellent in 7.52%, in 88.89 % of bleeds it was rated as good, and in 3.68% of bleeding events it was rated as moderate.

Pharmacokinetic assessment based on plasma Factor 8 activity measured by the chromogenic assay in 12 patients showed comparative results similar to F8 preparations.

Therefore, HemoRel-Awas established to be efficacious and safe in the treatment of acute bleeding events in subjects with severe hemophilia A.

Reference:

Mewada M, Sanyal S, Rangarajan S, et al. A prospective, multicenter, clinical Study to evaluate the Safety, Pharmacokinetics, and Efficacy of Bleed Outcomes, with HemoRel-A® in severe Hemophilia A Patients. J Assoc Physicians India 2022;70(7):72–75.