Pfizer said Tuesday that US and European regulators have accepted its filings seeking approval for a gene therapy that reduces bleed rates in hemophilia B patients — and that may compete with CSL Behring’s Hemgenix.
The FDA gave fidanacogene elaparvovec a PDUFA date in the second quarter of next year, according to the drugmaker.
In December, Pfizer revealed Phase III data that showed a 71% decrease in the rate of bleeding in patients who received the therapy. The trial, which enrolled 45 patients, had an average annualized bleed rate of 1.3 bleeds over 12 months. It met statistical significance — bringing in a p-value of p<0.0001.
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