Tillotts Pharma announces UK Medicines and Healthcare Products Regulatory Agency's approval of Entocort Capsules for Microscopic Colitis

RHEINFELDEN, Switzerland, February 5^th 2018 – Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new indication for Entocort^TM (budesonide) 3 mg capsules in the UK 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 diarrhoea. Although the incidence of MC and its subtypes, lymphocytic colitis (LC) and collagenous colitis (CC), has been rising over the past decade, awareness and treatment knowledge are still limited. In fact, some patients are misdiagnosed or take multiple years to have a proper diagnosis. With this approval, Entocort becomes the first budesonide available for both LC and CC in the UK, following similar approvals in over ten other European countries (Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Netherland (CC only), Norway, Poland, Slovak Republic and Sweden). Entocort is available in two formulations, capsule and enema, and is available in more than 40 countries.

“MC is a chronic and disabling condition that can be particularly challenging to diagnose.” says Robert Hofmann, MD, PhD, 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.”

The colonic mucosa of patients with MC appears normal on visual inspection by colonoscopy and therefore patients are often misdiagnosed. Additionally, LC and CC show similar signs and symptoms with the difference that LC causes an increase in the number of lymphocytes whilst CC is characterised by the thickening of the collagen band in the mucosa of the colon. Biopsies from the whole colon as well as histological examinations are often deemed necessary for the correct diagnosis.

“After eight months of chronic watery diarrhoea, weight loss and feeling very exhausted and tired, I was finally diagnosed with microscopic colitis. This was possible only after a colonoscopy when they took some tissue for examination,” according to a typical MC patient. “It changed my life. It was so stressful not being able to quickly find a bathroom, that I have avoided going anywhere.” Patients with MC can experience abdominal pain, faecal incontinence and weight loss; symptoms that heavily impair their quality of life. For active MC, short-term budesonide drugs are recommended as a first-line therapy (EMCG Guidelines: Munch et al. J Crohns Colitis 2012; 6(9):932-45. Epub 2012 Jun 15).