Pfizer Says US FDA Expands Hemophilia Drug Approval to Younger Patients

MT Newswires Live
06/08

Pfizer (PFE) said Monday that the US Food and Drug Administration has expanded approval for its drug Hympavzi, allowing is use in patients with hemophilia A or B aged 12 years and older with inhibitors, as well as in pediatric patients aged six to 11 years with or without inhibitors.

The company said the approval is based on a phase 3 study that showed that adults and adolescents with inhibitors who received the drug experienced about a 93% reduction in treated bleeding events compared with o-demand intravenous therapy.

In pediatric studies, patients treated with Hympavzi generally experienced far fewer bleeding episodes compared with expected rates under standard or historical treatments, it added.

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