Netherlands-based Janssen Biologics received a positive recommendation for its SIMPONI to treat moderate to severe ulcerative colitis, according to Pipeline Review.
SIMPONI is designed for patients who have had an inadequate response to other therapies or who may be intolerant to medicines used in conventional therapies.
The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, and a final decision from the European Commission is expected before the end of the year.
If approved, SIMPONI would be the only biologic therapy available for this patient population.
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