Shire debuts Lialda in USA

Following its approval by the US Food and Drug Administration earlier this year (Marketletter January 22), UK-headquartered Shire has launched its Lialda (mesalamine) with MMX Technology, indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis, a type of inflammatory bowel disease. The drug, which Shire has licensed from Italian firm Giuliani for the USA, Canada, Europe (excluding Italy) and the Pacific Rim, is the first and only FDA-approved once daily oral formulation of mesalamine, says the UK firm.

Lialda is available to patients by prescription for oral administration in dosages of 2.4g/day and 4.8g/day, allowing patients to 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, says Shire. A study found that patients who are not compliant with their mesalamine medications have a five-fold greater risk of disease flares, a serious worsening of symptoms, than compliant patients.

"In clinical trials, Lialda was superior to placebo in inducing remission. Additionally, Lialda's convenient once-daily dosing may help address the compliance issues facing so many ulcerative colitis patients," said Mike Cola, president of Shire's Specialty Pharmaceuticals business, noting that the drug "complements our existing GI portfolio and reinforces our commitment to improving the treatment of gastrointestinal diseases."