Remicade to treat ulcerative colitis in UK
pharmafile | April 12, 2006 | News story | Sales and Marketing |
Patients in the UK with ulcerative colitis could benefit from Remicade, the first new drug in years to be approved for the condition.
Ulcerative colitis (UC) is a long-term bowel disease that causes inflammation and ulceration of the lining of the rectum and colon, and is thought to affect between 60,000 and 120,000 people in the UK.
Marketed by Schering-Plough in the UK, Remicade is a well-established treatment for rheumatoid arthritis, and has been approved for a number of other diseases such as Crohn's disease, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Remicade (Infliximab) has now been shown to help ulcers on the wall of the intestine heal, which, combined with good safety and tolerability in patients, means it could be a significant advance on existing treatments.
"Ulcerative colitis is a distressing and embarrassing condition that can have a major impact on a patients ability to function normally and on their quality of life," said Dr. Jon Shaffer, a consultant gastroenterologist at Hope Hospital, Manchester. "Currently, there is an unmet need in terms of therapy options since many of the treatments that are available are associated with significant side effects or are unsuitable for long-term use."
The approval makes Remicade the first biologic treatment available for ulcerative colitis in the UK, and will boost sales for marketers Schering-Plough.
Statistics for prescribing in England in 2004 show Remicade to be one of the most prescribed hospital drugs, earning 36 million pounds in total, some way ahead of Wyeth's rival treatment Enbrel, which earned 27 million pounds that year.
Doctors will be able to prescribe the drug to patients with active ulcerative colitis who have had an inadequate response to conventional therapy such as corticosteroids and 6-MP or AZA (azathiaprine), or who are intolerant or have medical contraindications to these treatments.
The drug can also be used as maintenance therapy and so offers an effective, long-term approach to the management of UC, and may lead to a reduction in surgery.
Current standard treatment with corticosteroids has a number of undesirable side effects, and Schering-Plough says Remicade is likely to provide real added benefits.
"The approval of Remicade represents an important development in the management of ulcerative colitis. Clinical trials have shown that a significant proportion of patients receiving Remicade achieve clinical response, clinical remission and mucosal healing, with reduced levels of hospitalisation," said Professor Subrata Ghosh, the Chair in Gastroenterology at Londons Imperial College.
"These are significant results which demonstrate that this new treatment can be used as effective maintenance therapy in appropriate patients, which may reduce patient morbidity and improve quality of life."
Ulcerative colitis can progress to the stage where surgery is needed, however this is often not successful in the long-term. Even after a colectomy, the risk of the recurrence of inflammatory bowel disease, in the form of pouchitis, can be as high as 45%.
