The Medicines and Healthcare Products Regulatory Agency (MHRA) has expanded the approved uses of Tillotts Pharma’s Entocort to include the induction of remission in patients with active microscopic colitis (MC).
MC is an inflammation of the colon that causes chronic, non-bloody, watery diarrhea, and incidence of the condition and its subtypes, lymphocytic colitis (LC) and collagenous colitis (CC), has been on the rise over the past decade.
The approval sees Entocort (budesonide) become the first budesonide available for both LC and CC in the UK, following similar approvals in over ten other European countries, the firm noted.
“MC is a chronic and disabling condition that can be particularly challenging to diagnose,” noted Robert Hofmann, medical director at Tillotts. “Proper diagnosis and regular follow-ups are important to offer a treatment that can improve the patient’s quality of life.”
Tillotts picked up rights to Entocort, a first-line anti-inflammatory agent and locally acting glucocorticosteroid indicated for the induction and maintenance of remission of mild to moderate ileocaecal Crohn’s disease, ulcerative colitis and now induction of remission of active microscopic colitis, from GlaxoSmithKline in 2015, in a deal valued at $215 million.
Tillotts is a Swiss-based subsidiary of Japanese group Zeria.