Posted by Michael Wonder on 09 Jul 2018
Simponi (golimumab) receives European Commission approval for early dose optimisation treatment in patients with ulcerative colitis
9 July 2018 - Approval follows positive opinion by the CHMP and analyses of the PURSUIT-Maintenance study.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved Simponi (golimumab) for early dose optimisation for patients living with moderate to severe ulcerative colitis (UC) with a body weight of less than 80 kg who have not responded adequately to induction therapy (the first two doses of Simponi).
Based on data from post-hoc analyses of the pivotal Phase 3 PURSUIT-Maintenance study evaluating Simponi in adult patients with moderate to severe UC, the EC approval indicates that patients weighing less than 80 kg who do not demonstrate an adequate response at week 6 to Simponi following the initial 200 mg subcutaneous injection and second 100 mg dose at week 2 may benefit from continuing with 100 mg every four weeks.
The EC approval follows a positive opinion issued by the CHMP of the EMA in May 2018.
