Looking to lift clinical hold, uniQure contends its gene therapy was likely not the cause of single liver cancer case
Slapped with a clinical hold from the FDA back in December, uniQure’s lead gene therapy program has sat on ice as it waited for a final say on what led to a single liver cancer case. Now, with multiple investigators’ backing, uniQure is arguing that its therapy and that cancer case were likely not linked — and a filing could be in the offing.
UniQure believes its gene therapy etranacogene dezaparvovec was “highly unlikely” to have caused a case of hepatocellular carcinoma that led to the FDA placing a clinical hold on the drug, the biotech said Monday.
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