Biotech Values

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FDA places NVS HCV program Deb025 on clinical hold after pancreatitis cases and death

Swiss drugmaker Novartis said on Thursday that U.S. health regulators had put is development programme for a treatment of hepatitus C on hold after one patient's death was reported in a clinical trial.

The company said a small number of patients being treated with DEB025 (alisporivir) in combination with pegylated interferon and ribavirin were diagnosed with pancreatitis. One case resulted in a patient's death, although the cause of death is still being dertermined.

"As a result, Novartis has been notified by the FDA that the development program of DEB025 being studied for the treatment of Hepatitis C, will be placed on full clinical hold," the company said in a statement.