Washington DC – 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.
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.
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.
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Carla Cox
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