"It is very exciting to reach this milestone in the process of seeking FDA approval of Entocort™,” said Doug Levine, Chief Medical Officer, Gastrointestinal Therapeutic Area, AstraZeneca. "Crohn's disease is one of a group of several diseases affecting the gastrointestinal tract, known collectively as inflammatory bowel diseases (IBD), and can be painful and debilitating.”

Crohn's disease is a chronic inflammatory bowel disease of unknown origin. Flare-ups of the disease can range from mild to severe and involve symptoms such as diarrhoea, abdominal pain, fever and gastrointestinal bleeding. The condition can be difficult to manage, clinically. Treatment tends to consume a substantial amount of healthcare resources in terms of physician time, procedures and medications.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.