Pfizer said a late-stage study of its Hympavzi hemophilia drug met its key goals in patients with the blood-clotting disorder who have inhibitors that can render some treatments ineffective.
Pfizer on Thursday said the Phase 3 study of Hympavzi in patients 12 and older with hemophilia A or B with inhibitors met its primary endpoint and key secondary bleeding endpoints, showing a statistically significant and clinically meaningful reduction in annualized bleeding rate compared to on-demand treatment.
The New York drugmaker said it plans to discuss the study data with regulatory authorities with the goal of initiating regulatory filings.
Pfizer said about 20% of people with hemophilia A and 3% of those with hemophilia B are unable to continue taking factor replacement therapies because they develop inhibitors, or antibodies, that neutralize the therapies.
Hympavzi, a once-weekly subcutaneous treatment, is already approved in the U.S. and Europe for patients living hemophilia A or B without inhibitors.
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