FDA approves new treatment regimen for ulcerative colitis

The U.S. Food and Drug Administration approved the use of a once-monthly single-injection maintenance regimen of mirikizumab-mrkz (Omvoh; Eli Lilly and Company) to treat moderately to severely active ulcerative colitis.

The approval followed positive results from a Phase 1 study demonstrating bioequivalence between the new regimen and a previously approved regimen, according to a news report from Pharmacy Times. Maintenance therapy with mirikizumab is designed to follow induction with three 300-milligram intravenous infusions received once every four weeks.

Clinicians were advised to monitor patients for common adverse effects of mirikizumab, including headaches, joint pain, injection-site reactions, upper respiratory infections and hepatic enzyme elevations.

Read more: Pharmacy Times

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