New Jersey-based multinational MSD have announced that the European Commission (EC) has approved Simponi (golimumab) for early dose optimisation in ulcerative colitis (UC) for patients with body weight less than 80kg who do not respond adequately to induction therapy.
The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in May 2018, based on findings from post-hoc analyses 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, Vice President General Medicine Medical Affairs at 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 offers hope for those who suffer from the chronic inflammatory bowel disease of which there are more than 1.5 million in Europe alone.
As noted by Dr George Philip, Executive Director, Clinical Research, at MSD: “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.”
The monoclonal antibody Simponi, which is a subcutaneous (SC) anti-tumour necrosis factor (TNF)-alpha treatment, has been indicated for moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy.