Eli Lilly and Company LLY announced that the FDA has granted approval to its drug, Omvoh (mirikizumab), for its second inflammatory bowel disease (IBD) condition, Crohn's disease (“CD”), in the United States. Omvoh was approved for its first IBD indication, moderately to severely active ulcerative colitis (“UC”), in 2023. The drug is currently approved for UC in 44 countries.

The approval of Omvoh for moderately to severely active CD in adults was based on data from the VIVID 1 study. The study met both its co-primary endpoints, showing significant improvement in clinical remission and endoscopic response at one year.

Lilly is also studying Omvoh in the VIVID-2 open-label extension (OLE) study, evaluating the drug for up to three years in adults with moderately to severely active Crohn's disease. Among the patients who achieved clinical remission and endoscopic response at one year in the VIVID-1 study, almost 90% maintained clinical remission with two years of continuous treatment with Omvoh in VIVID-2 OLE study.

Lilly’s stock has risen 18.7% in the past year against a decrease of 3.9% for the industry.

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LLY Seeks Approval of Omvoh for CD in Other Countries

Lilly has also filed applications seeking approval of Omvoh for CD in several countries, including the EU and Japan. In December, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending the approval of Omvoh for the CD indication. Omvoh should be approved in the EU soon.

IBD Space Gaining Immense Popularity

In recent years, there has been a surge in the prevalence of IBD conditions, CD and UC, both characterized by chronic inflammation in the gastrointestinal tract.

There has been a rapid increase in cases of CD and UC due to genetic factors, environmental factors and lifestyle changes. In addition, immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries are driving demand for IBD treatments.

Several big drugmakers are developing new medicines to treat UC and CD with novel mechanisms of action to help patients achieve long-term clinical remission. Large drugmakers are acquiring smaller biotechs, making IBD candidates with improved clinical profiles.

In 2024, Lilly acquired Morphic Therapeutics, which added its pipeline candidate MORF-057, an oral α4β7 inhibitor with the potential to improve outcomes in treating IBD conditions.

AbbVie ABBV has been on an acquisition spree lately in the IBD space. In 2024, it acquired smaller biotechs like Landos Biopharma and Celsius Therapeutics, which are making novel drugs for treating IBD. It also signed a license agreement with China’s FutureGen to develop a next-generation anti-TL1A antibody for IBD. Its successful immunology drug Rinvoq is approved for treating both UC and CD, where the drug’s uptake continues to be very strong. Its other blockbuster medicine, Skyrizi, is seeing tremendous performance in CD. The company expects rapid access to the UC indication, for which approval was received in the United States and EU in mid-2024.

Merck MRK acquired small biotech Prometheus Biosciences in 2023, which added tulisokibart to its pipeline. Merck is developing tulisokibart, a novel TL1A inhibitor, for the treatment of UC, CD and other autoimmune conditions.

Sanofi SNY in-licensed rights to jointly develop and commercialize Teva Pharmaceutical’s IBD candidate, duvakitug, an anti-TL1A therapy, in 2023. In December last year, Sanofi and Teva announced that a phase IIb study evaluating duvakitug for treating UC and CD met its primary endpoints

LLY’s Zacks Rank

Lilly has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Eli Lilly and Company Price and Consensus

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