Shire Pharmaceuticals says that the US Food and Drug Administration has approved the company’s Lialda for inducing remission in patients with active, mild to moderate ulcerative colitis.
Lialda (mesalamine) is the first and only FDA-approved once-daily oral formulation of mesalamine, the company noted. The approval was based on the results of two Phase III clinical studies that found the drug (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.
The drug is generally well tolerated and has a similar safety profile to other currently available mesalamines, Shire added, noting that patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and six to 16 pills a day and a recent study conducted by the Crohn's and Colitis Foundation of America found that 65 % of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden.
Lialda uses a drug delivery technology developed by Italian firm Cosmo, and the treatment itself was licensed by Shire from another Italian company, Giuliani.
The approval “is one of several medicines Shire expects to launch in the US and Europe in 2007,” said chief executive Matthew Emmens. The company has only just finished celebrating the decision by the European Commission to granted marketing approval to Elaprase (idursulfase) for the long-term treatment of patients with the rare genetic disorder Hunter syndrome and analysts believe that Shire is starting to move away from its reliance on attention deficit hyperactivity disorder drug Adderall XR (mixed amphetamine salts).