Johnson & Johnson JNJ announced that it has submitted a regulatory filing with the FDA seeking approval for the use of a subcutaneous (SC) induction regimen of its blockbuster immunology medicine Tremfya (guselkumab) in ulcerative colitis (UC) indication.

The FDA recently approved Tremfya to treat adults with moderately to severely active UC as both an induction and maintenance therapy. However, the induction dose of the drug can only be administered as an intravenous (IV) therapy. The maintenance dose of the drug is already approved for SC administration.

J&J intends to provide UC patients with a more convenient alternative to start treatment with Tremfya. Compared to an IV dose, an SC dose requires less time to administer and is also claimed to be more comfortable.

If this regulatory filing is approved, the J&J drug will be the first IL-23 inhibitor to offer a choice of IV or SC administration as induction therapy in the UC indication.

This latest submission is based on data from the phase III ASTRO study, which achieved its primary endpoint of clinical remission at week 12. The study also achieved all secondary endpoints. The results from the ASTRO study were also consistent with those from the phase IIb/III QUASAR study, which supported the approval for Tremfya IV as induction therapy in UC patients.

JNJ Stock Performance

Year to date, J&J’s shares have lost 1.0% against the industry’s 5.7% growth.

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Recent Developments With J&J’s Tremfya

Tremfya is already approved for plaque psoriasis and active psoriatic arthritis (PsA) indications in several countries, including the United States and Europe. A regulatory filing for the drug in the UC indication is currently under review with the EMA.

J&J also submitted a filing for Tremfya in June seeking label expansion for a fourth indication — moderately to severely active Crohn’s disease (CD). A similar regulatory filing is also under the EMA’s review.

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 are driving demand for IBD treatments.

Although J&J already has a presence in the IBD space with its blockbuster drug Stelara, the drug is expected to lose market exclusivity in the United States next year. Sales will also be negatively impacted as Stelara is one of the 10 drugs selected for a price cut under the U.S. government’s drug price negotiation program — part of the Inflation Reduction Act of 2022 (IRA) —starting in 2026. Considering these factors, the label expansion of Tremfya will likely help J&J drive the top line and compensate for the potential fall in Stelara sales.

Tremfya is an important drug in J&J’s immunology drug portfolio and a key top-line growth driver. The drug generated sales of $2.7 billion in the first nine months of 2024, up 22% year over year, driven by strong market growth and share gains. J&J expects Tremfya to be a $5-billion product with potential approvals across both IBD indications.

Competition in the IBD Space

The targeted market in the IBD space is highly competitive. A key player in this space is AbbVie ABBV, which has one of the strongest portfolios of immunology drugs and pipeline candidates. ABBV’s immunology products, Skyrizi and Rinvoq, are performing extremely well, bolstered by approval in new indications, which should support top-line growth in the next few years. Both AbbVie drugs are approved for multiple immunology indications, including UC, CD and PsA.

Another pharma giant that made its foray into the IBD space is Eli Lilly LLY, following the FDA approval of Omvoh in the UC indication last year. It was the first LLY drug to be approved for a type of IBD in the United States and is important for growth of its immunology portfolio. A regulatory filing is already under the FDA’s review seeking label expansion for the Lilly drug in CD indication.

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