Daily Newsletter

30 October 2023

Daily Newsletter

30 October 2023

Eli Lilly’s Omvoh scores FDA approval for ulcerative colitis after past rejection

The FDA rejected Omvoh’s (mirikizumab) BLA over manufacturing concerns in April 2023.

Phalguni Deswal October 27 2023

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.

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.

Analyzing the key M&A trends in the Contract Manufacturing industry

Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent and Recipharm were particularly active in acquiring companies during this period, and these acquisitions had a focus on advanced biologic capabilities related to cell and gene therapies. CMOs are increasingly targeting companies with sophisticated (biologic and specialized) capabilities to manufacture modern drugs and seek high-value contracts.

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