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2018.02.05

Tillotts Pharma announces MHRA1 approval of EntocortTM Capsules for Microscopic Colitis

PRESS RELEASE

RHEINFELDEN, Switzerland, February 5th 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 EntocortTM (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 countries2. 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 therapy3.

Press Release for Switzerland, please click here
Press Release for Germany, please click here

About EntocortTM

Entocort (budesonide) is 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 (Entocort capsules) and ulcerative colitis (Entocort enemas) as well as for the induction of remission of active microscopic colitis (Entocort capsules). Specific indications and instructions for use vary by country.

Important Safety Information

Most common side effects are summarised in the international summary of product characteristics (SmPC): https://www.tillotts.com/wp-content/uploads/2017/10/201709-Entocort-international-API-Update-combined-based-on-CCDS.pdf. For the UK, please refer to the SmPC on the MHRA website:

Reporting of Side Effects

At Tillotts Pharma, we continuously monitor the safety of our products by collecting information regarding side effects associated with their use. Healthcare providers are encouraged to report adverse events by completing our online form in the section “Product Safety” here. In the UK, you can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

For more information, contact Federica Ricatto, Senior Communications Manager, Medical Affairs:
Phone: +41 61 935 2749 | Email:   FRicatto@tillotts.com
For the UK, contact UKmedinfo@tillotts.com

About Tillotts

Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with approximately 300 employees in Switzerland and abroad. Tillotts is engaged in advancing care and is committed to making a difference for the millions of people worldwide who suffer from GI-diseases.

All trademarks used or mentioned here are protected by law. © Copyright Tillotts Pharma AG. All rights reserved.

About Zeria

Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, operates internationally through a number of subsidiaries in the Ethical Pharmaceuticals and Consumer Healthcare businesses. Zeria is dedicated to research and development of pharmaceutical products and is specialised in the gastroenterology field, among others. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559).

Notes & References

  1. UK Medicines and Healthcare Products Regulatory Agency
  2. Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Netherland (CC only), Norway, Poland, Slovak Republic and Sweden.
  3. EMCG Guidelines: Munch et al. J Crohns Colitis 2012; 6(9):932-45. Epub 2012 Jun 15

Download high resolution photos: https://www.tillotts.com/about-us/visuals/