Biotie receives positive opinion on orphan drug status for BTT1023 from EMA

17 February 2015
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Finnish biotech and pharma company Biotie has received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products, recommending orphan drug designation for BTT1023 in primary sclerosing cholangitis.

This is a chronic, progressive fibrotic liver disease for which there are currently no effective treatments.

BTT1023 is a fully human monoclonal antibody that targets vascular adhesion protein -1, and is currently advancing into Phase II clinical development. The BUTEO study will be an open label, single arm, multicenter investigator-sponsored study that will be conducted in partnership with the University of Birmingham, UK and supported through external grant funding.

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