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news.The FDA has approved Prometheus Laboratories' supplemental new drug application for the additional use of Entocort EC capsules in mild to moderate Crohn's disease involving the ileum and/or the ascending colon.
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Entocort EC (budesonide) is a topical glucocorticosteriod, working primarily in the intestines. It is the only pharmacological product indicated for the treatment of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon, which affects nearly 70% of Crohn’s patients.
The additional approval is based on the results of four double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with either 3mg or 6mg Entocort EC, or placebo.
The median time to relapse in the pooled population of the four studies was 154 days for patients taking placebo, and 268 days for patients taking Entocort EC, at 6mg/day. Entocort EC at 6 mg/day also significantly reduced the percentage of patients with loss of symptom control (28%) versus placebo (45%) in the pooled population for the four studies at three months.
“We are excited to have this additional indication for Entocort EC,” said Joseph Limber, president and CEO of Prometheus. “Physicians can now provide their patients with an effective long-term therapy option, in addition to an acute treatment related to mild to moderate active Crohn’s disease.”