Eli Lilly LLY announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn’s disease (CD).

The CHMP has recommended Omvoh to treat adults with moderately to severely active CD, who have had an inadequate response with, lost response to, or are intolerant to conventional or biologic therapies. A final decision from the European Commission is now expected in the next one or two months.

This positive recommendation is based on data from the phase III VIVID-1 study, which showed that treatment with Omvoh was effective in CD patients with or without prior biologic failure. Per Lilly, this is the first pivotal study to show benefit in hard-to-treat CD patients. A similar regulatory filing for the drug is also under review with the FDA with a final decision expected in first-half 2025, also supported by data from the VIVID-1 study.

Omvoh is currently approved in more than 44 countries, including the United States and Europe, to treat adults with moderate-to-severely active ulcerative colitis (“UC”).

LLY Stock’s Performance

Year to date, Eli Lilly’s shares have risen 35.4% compared with the industry’s 6.3% growth.

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Competition in the IBD Space

Both UC and CD indications are primary forms of inflammatory bowel disease (IBD), marked by chronic inflammation in the gastrointestinal tract. In recent years, there has been a surge in the prevalence of these disorders due to genetic factors, environmental factors and lifestyle changes. Immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries drive the demand for IBD treatments.

The targeted IBD market is highly competitive. Some key players in this space are AbbVie ABBV and Johnson & Johnson JNJ, which have the strongest portfolios of immunology drugs and pipeline candidates.

ABBV’s key immunology products, Skyrizi and Rinvoq, are performing extremely well, bolstered by approval across multiple IBD indications, which should support top-line growth in the next few years. AbbVie has already raked in nearly $10 billion from the combined product sales of both these drugs in the first nine months of 2024.

ABBV has also been engaged in an acquisition spree since the onset of this year to further strengthen its leadership in the immunology space. In 2024, it acquired smaller biotechs, Landos Biopharma and Celsius Therapeutics, which are making novel drugs for treating IBD. Last week, ABBV announced its intent to acquire privately-held Nimble Therapeutics for $200 million in cash to explore the potential of novel oral therapies in the immunology space.

J&J also boasts a strong immunology portfolio with blockbusters like Stelara and Tremfya. A much older drug, Stelara is already approved to treat several IBD indications, including CD and UC, across the United States and the European Union. J&J added more than $8 billion from Stelara sales in the first nine months of 2024.

Another successful drug in J&J’s portfolio is its newer immunology drug, Tremfya, which recorded sales of $2.7 billion in the first nine months of 2024. Tremfya was approved by the FDA for UC indication in September, with a similar regulatory filing under review in the European Union. It is also under review in both the United States and the European Union for CD indication. J&J expects Tremfya to be a $5 billion product with potential approvals in both CD and UC indications.

Several other big drugmakers are developing new medicines with novel mechanisms of action to help patients with UC and CV achieve long-term clinical remission. These include Merck, Pfizer, Novartis, Sanofi, Gilead and Amgen. Some of these companies have also in-licensed rights to IBD candidates with improved clinical profiles from smaller drugmakers in the past two to three years.

Eli Lilly and Company Price

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LLY’s Zacks Rank

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

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