A label change for MSD’s (known as Merck in the US and Canada) ulcerative colitis (UC) treatment — SIMPONI (golimumab) — has received approval from the European Commission.
Regulatory approval
The change now includes use of the treatment for early dose optimisation in UC patients who have a body weight less than 80 kg who do not respond adequately to induction therapy.
This decision follows on from the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) earlier this year (May 2018) that had been based on the findings from a post-hoc analysis of the PURSUIT induction and maintenance studies.
“The European Commission approval of early dose optimisation of golimumab for ulcerative colitis patients not adequately responding to induction is an important milestone for these patients and their gastroenterologists,” said Dr Björn Oddens, PhD, vice president General Medicine Medical Affairs, MSD. “We are pleased that with early dose optimisation 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 zero and 100 mg at week two, followed by a maintenance dose at week six 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 100 mg every 4 weeks.
“Optimising 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,” explained Dr George Philip, executive director, Clinical Research, MSD Research Laboratories.