Eli Lilly’s Omvoh (mirikizumab) secured approval from the US Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis (UC) in adults after a past rejection earlier this year.

In April, the agency rejected the biologic licence application (BLA) for Omvoh citing manufacturing concerns. The anti-interleukin (IL)-23 therapy is approved for treating UC in Japan and the European Union. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

UC is a type of inflammatory bowel disease that causes symptoms such as diarrhoea and constipation. Multiple drugs have been approved for the treatment of inflammatory bowel disease.

Omvoh will arrive at a market that features established high-grossing drugs for UC treatment such as AbbVie’s Humira (adalimumab) and Janssen’s Stelara (ustekinumab). The drugs generated $4bn and $4.8bn, respectively in H1 2023, as per the companies’ Q2 2023 financials.

This year marked the arrival of Humira biosimilars to the US market, which has already caused a decline in profits for AbbVie. The company reported a 26% and 19.8% decline in the US and international Humira H1 2023 revenues, as per the company’s Q2 2023 financials.

GlobalData forecasts Omvoh to generate $1.2bn in global sales in 2029.

GlobalData is the parent company of Pharmaceutical Technology.

The FDA approval was based on the Phase III LUCENT trials (NCT03518086 and NCT03524092) in patients with UC who have received prior treatment. Nearly 65% of the patients achieved clinical response, with 24% of the patients showing clinical remission compared to placebo after 12 weeks of therapy.

Omvoh treatment also improved ulcerative colitis symptoms such as rectal bleeding and stool frequency. The commonly observed side effects seen with Omvoh included upper respiratory infections, injection site reactions, and herpes viral infection.

Other new approvals for UC treatment include the US FDA approval for Pfizer’s Velsipity (etasimod), a once-daily oral selective sphingosine-1-phosphate (S1P) receptor modulator.