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Related Topics >> FDA | BLA | Crohn's disease | UCB | Belgium | Biologics

UCB submits BLA for Cimzia

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Belgium's UCB has submitted a BLA to the FDA for Cimzia as a treatment for Crohn's disease. And the developer says it plans to file a European submission in a matter of weeks. If approved, Cimzia would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.

"Our experience in the PRECiSE clinical trials program has shown Cimzia to be a well-tolerated and effective treatment," said William Sandborn, M.D., professor of medicine at the Mayo Clinic College of Medicine and a leading investigator in the Cimzia program. "In addition, subcutaneous administration is a welcomed attribute for patients and can offer greater convenience."

- read the report from AFX

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