Health regulators in Canada have given the all clear for a new indication for Shire's Mezavant, approving its use for the maintenance of remission of ulcerative colitis.
Mezavant (mesalamine delayed and extended release tablets) is already the first and only once-daily mesalamine therapy indicated for the induction of clinical and endoscopic remission in patients with mild-to-moderate forms of the disease.
With Health Canada's go-ahead, the drug is now also the first and only once-daily treatment available for the maintenance of remission in patients with ulcerative colitis, an inflammatory bowel disease that affects around 65,000 Canadians.
The fact that Mezavant only needs to be taken once a day compared to other mesalamine options, which require multiple daily doses of up to eight pills per day, offers a significant advantage that could give the product the edge over its competitors.
"In a chronic disease such as UC, consistent use of medication is required to maintain remission," explained Hillary Steinhart, head of Gastroenterology at Mount Sinai Hospital. "However, the lack of symptoms during remission and the complicated treatment regimens associated with most 5-ASAs may lead to non-adherence and in turn, increased disease activity and reduced quality of life," he said, highlighting the drug's potential benefit.
Mezavant generated sales of $87.1 million for Shire in the first quarter.