MSD announces EC approval for SIMPONI (golimumab) label change allowing dose optimization for induction in patients with ulcerative colitis

Golimumab non responders to induction show one-year outcomes similar to responders when dose is optimized early after induction
 
Lucerne, 9thth July, 2018 – MSD (known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada) announced today that the European Commission (EC) has approved SIMPONI® (golimumab) for early dose optimization in ulcerative colitis (UC) for patients with body weight less than 80 kg who do not respond adequately to induction therapy. This follows CHMP positive opinion issued in May 2018, which was based on the findings from post-hoc analyses of the PURSUIT induction and maintenance studies.
 
“The European Commission approval of early dose optimization of golimumab for ulcerative colitis patients not adequately responding to induction is an important milestone for these patients and their gastroenterologists,” said Björn Oddens, M.D., PhD., Vice President General Medicine Medical Affairs, MSD. “We are pleased that with early dose optimization of golimumab, more patients achieve the full long-term clinical, endoscopic, and quality of life benefits from golimumab treatment.”
 
The approved posology for UC has induction doses of 200 mg at week 0 and 100 mg at week 2, followed by a maintenance dose at week 6 and every four weeks (q4w) thereafter. For maintenance, 100 mg q4w is approved for patients weighing ≥80 kg and 50 mg q4w is approved for patients weighing <80 kg unless they are not achieving an adequate response, whereby they may now benefit from 100mg every 4 weeks.

Selection of the 100 mg q4w maintenance regimen for the subpopulation of patients weighing ≥80 kg follows the observed trend in the PURSUIT-Maintenance study toward greater clinical benefit of 100mg compared to 50mg golimumab with increasing body weight.

Thus, for maintenance, 100 mg q4w is approved for patients weighing ≥80 kg and 50 mg q4w is approved for patients weighing <80 kg unless they are not achieving an adequate response, whereby they can now benefit from 100mg every 4 weeks based on the new approval of early dose optimization of golimumab.

“Optimizing the dose in this subset of patients who are not adequately responding to treatment at an early stage may allow more patients to attain an adequate clinical response”, said George Philip, M.D., Executive Director, Clinical Research, MSD Research Laboratories.

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