Pharmaceutical company Zeria has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Zentacort 3mg capsules, which will used to treat Crohn's Disease (CD).
Last July, Zerica acquired worldwide rights to Entocort (except in the US) from AstraZeneca, and submitted the new drug application in October 2015 in Japan.
Tillotts sells Zentacort as Entocort in more than 40 countries, and it is suggested as the first line therapy for treatment in CD under many international guidelines.
Tillotts CEO Thomas Tóth von Kiskér said: "Tillotts is pleased that Zentacort will be introduced in Japan through Zeria.
"This approval further reinforces Tillotts' commitment as a leading specialist in the field of gastroenterology on a European and worldwide basis, offering patients a broad range of treatments for GI diseases."
Tillotts also sells Entocort for treating ulcerative colitis (UC) in some countries.
CD and UC are types of inflammatory bowel diseases (IBD), one of the most commonly found gastrointestinal (GI) diseases that affect more than 2.2 million people in Europe and 5 million worldwide.
The drug is recommended for the treatment of mild to moderate active CD and, in some markets, ulcerative colitis (UC).
Zentacort is an enteric-coated, sustained release formulation that is designed to release budesonide in the small intestine and the proximal colon.
Tillotts chairman Sachiaki Ibe and Zeria CEO have declared: "We are extremely happy to introduce a product such as Zentacort in Japan, where the prevalence of CD is increasing, and to offer patients a well-established treatment."
Zeria expects that the approval of this new drug will make a significant contribution to treatment of mild to moderate CD in Japan.