European Union Approves Cortiment for Ulcerative Colitis

Larry Hand

Disclosures

October 23, 2014

The European Union (EU) has approved the marketing of budesonide (Cortiment, Ferring Pharmaceuticals) as a treatment for induction of remission in adults with mild to moderate ulcerative colitis, according to the company. The approval is effective for 27 EU states.

Budesonide, a glucocorticosteroid, is approved in the United States (Uceris, Salix Pharmaceuticals), as well as the Netherlands, Asia (except for Japan), Australia, Canada, Latin America, and Africa. Budesonide also is marketed under other brand names.

The EU approval is for a dosing regimen of a single 9-mg tablet once daily for up to 8 weeks. Cortiment incorporates budesonide into a tablet using multimatrix colonic delivery technology, which allows controlled release of budesonide throughout the colon.

Cosmo Pharmaceuticals of Lainate, Italy, developed the drug and licensed its marketing to Ferring Pharmaceuticals of Saint Prex, Switzerland.

In phase 3 studies, up to 3.9 times more patients had clinical and endoscopic remission from ulcerative colitis with Cortiment compared with placebo, with no clinically significant glucocorticosteroid adverse effects, according to a news release from Ferring.

"Well over two million people in Europe suffer from ulcerative colitis. Cortiment, with its proven efficacy and safety profile, will provide an important new option for physicians treating active, mild to moderate ulcerative colitis," Simon Travis, DPhil, a consultant gastroenterologist at Oxford University and the John Radcliffe Hospital, Oxford, United Kingdom, said in the release.

Ulcerative colitis, a form of inflammatory bowel disease, is a chronic relapsing-remitting disease with no known cure but with manageable symptoms. It produces inflammation and ulcers inside the colon.

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