Pfizer Says US FDA Expands Hemophilia Drug Approval to Younger Patients
MT Newswires Live
Jun 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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