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Janssen-Cilag seeks European approval for guselkumab in ulcerative colitis and Crohn's disease treatment

Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease. ....

David Lee , European Medicines Agency , Drug Administration , European Union , Janssen Cilag International , Marketing Authorization Application , Ludovic De Beaucoudrey , Senior Director , Therapeutic Area Lead , Janssen Cilag Limited , Global Therapeutic Area Head Immunology , Johnson Innovative , Disease Week Annual Meeting , United European Gastroenterology Week , Biologics License Application , Crohns Disease , Ulcerative Colitis ,

Johnson & Johnson submits regulatory applications to

Media contact:Sophie [email protected]+33 6 3178 8798Investor contact:Raychel [email protected] For European and UK. ....

United Kingdom , Region Flamande , David Lee , Sophie Daneau , Drug Administration , Japan Pharmaceuticals , Exchange Commission , European Union , Canadian Agency For Drugs Technologies In Health , Janssen Biotech Inc , Crohn Colitis Foundation , None Of Janssen Research Development , Devices Agency , Janssen Research Development , European Medicines Agency , Janssen Cilag International , Marketing Authorisation Application , Ludovic De Beaucoudrey , Senior Director , Therapeutic Area Lead , Janssen Cilag Limited , Global Therapeutic Area Head Immunology , Johnson Innovative , Disease Week Annual Meeting , United European Gastroenterology Week , Biologics License Application ,

J&J Submits sBLA To FDA for Guselkumab in Ulcerative Colitis

Individuals included in the study reported positive changes in fatigue, and disease activity displayed endoscopic and histologic remission.
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David Lee , Biologics License Application , Global Therapeutic Area Head Immunology ,