Lialda®/Mezavant®/Mesavancol® is a once-daily mesalamine tablet approved to help get active, mild to moderate ulcerative colitis into remission.
This medication belongs to a class of drugs called aminosalicylates, which are also known as 5-ASAs. The specific pharmaceutical product dissolution profile increases the colonic specific disposition of mesalazine, reduces the pre-colonic systematic absorption and allows the product to be especially effective for the treatment of both proximal and distal ulcerative colitis.
The application of the MMX® technology reduces the number of tablets which patients taking mesalazine in non-acute phases have to take, to approximately two tablets a day, and to three to four tablets per day during acute phases of ulcerative colitis. The reduction in the number of tablets required compared with the standard oral administration of mesalazine results in an increase in medication adherence.
Lialda®/Mezavant® was out-licensed to Giuliani S.p.A./Takeda (formerly Shire plc) in 2001.
Lialda® was approved by the FDA in 2007 based on the results of two phase III clinical studies that found Lialda (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo after eight weeks of treatment.
Lialda® is indicated for the induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis and the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.
In 2018, a generic of Lialda was launched in the U.S. market.
In 2021, Cosmo reported manufacturing and royalty income of €27.8M (2020: €27.6M)
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