Pfizer Announces Positive Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors, Plans Regulatory Submission

Intelligent Finance APP learned that pharmaceutical giant Pfizer (PFE.US) announced on Thursday that its once-weekly injectable hemophilia treatment drug Hympavzi succeeded in a Phase III clinical trial targeting patients who have developed neutralizing antibodies to factor replacement therapy.

Pfizer cited the topline data from the Phase III BASIS study, stating that Hympavzi achieved a statistically significant and clinically meaningful reduction in annualized bleeding rate over 12 months compared to on-demand treatment, meeting the primary endpoint of the trial.

This open-label trial enrolled adolescent and adult patients with hemophilia A and B, with result analysis focusing on 48 hemophilia patients who developed inhibitors – such inhibitors occur in approximately 20% of hemophilia A patients and 3% of hemophilia B patients.

Pfizer stated that Hympavzi outperformed the control therapy in all bleeding-related secondary endpoints, including spontaneous bleeding, joint bleeding, and total number of bleeding episodes. In terms of safety, the experimental therapy was well-tolerated with no deaths or thromboembolic events reported.

Pfizer Plans to Share Study Results with Drug Regulators, Aiming to Submit Marketing Application for New Drug Hympavzi in Hemophilia Patients with Inhibitors.