FDA Lifts Hold on uniQure’s Gene Therapy AMT-061 for Hemophilia B

FDA Lifts Hold on uniQure’s Gene Therapy AMT-061 for Hemophilia B

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FDA Lifts Hold on uniQure’s Gene Therapy AMT-061 for Hemophilia B

The U.S. Food and Drug Administration (FDA) has lifted its clinical hold on uniQure’s gene therapy program for hemophilia B, which includes AMT-061 (etranacogene dezaparvovec), the company announced. According to uniQure, the FDA found it was “very unlikely” that AMT-061 had contributed to a case of liver cancer in a patient who had received the therapy during the Phase 3 HOPE-B trial (NCT03569891). The regulatory agency’s decision to release the hold was based on the satisfactory resolution of all issues identified…

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