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FDA Grants Label Expansion to J&J's Tremfya in Ulcerative Colitis
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Johnson & Johnson (JNJ - Free Report) announced that the FDA approved its blockbuster immunology medicine, Tremfya (guselkumab), for a third indication. The drug is approved to treat adults with moderately to severely active ulcerative colitis (UC).
Tremfya is already approved for plaque psoriasis and active psoriatic arthritis (PsA) indications in several countries, including the United States and Europe.
This latest approval is based on data from the phase IIb/III QUASAR study, which showed that a significantly greater percentage of UC patients treated with Tremfya achieved clinical remission at week 44 compared with placebo. A regulatory filing for the drug based on this study is currently under review with the EMA seeking approval for UC indication.
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.
J&J Boasts $5B Revenue Opportunity From Tremfya
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 further as Stelara is also 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 to Tremfya will likely help J&J drive the top line and make up for the potential fall in Stelara sales.
Tremfya is an important drug in J&J’s immunology drug portfolio and a key driver of top-line growth. The drug generated sales of $1.7 billion in the first half of 2024, up 29% 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.
JNJ Stock Performance
Year to date, J&J’s shares have moved up 5.1% compared with the industry’s 24.2% rise.
Image Source: Zacks Investment Research
Competition in the IBD Space
The targeted market in the IBD space is highly competitive. A key player in this space is AbbVie (ABBV - Free Report) , 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 across multiple immunology indications, including UC, CD and PsA.
Another pharma giant that made its foray into the IBD space is Eli Lilly (LLY - Free Report) , following the FDA approval of Omvoh in UC indication last year in October. 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.
Johnson & Johnson (JNJ - Free Report) announced that the FDA approved its blockbuster immunology medicine, Tremfya (guselkumab), for a third indication. The drug is approved to treat adults with moderately to severely active ulcerative colitis (UC).
Tremfya is already approved for plaque psoriasis and active psoriatic arthritis (PsA) indications in several countries, including the United States and Europe.
This latest approval is based on data from the phase IIb/III QUASAR study, which showed that a significantly greater percentage of UC patients treated with Tremfya achieved clinical remission at week 44 compared with placebo. A regulatory filing for the drug based on this study is currently under review with the EMA seeking approval for UC indication.
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.
J&J Boasts $5B Revenue Opportunity From Tremfya
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 further as Stelara is also 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 to Tremfya will likely help J&J drive the top line and make up for the potential fall in Stelara sales.
Tremfya is an important drug in J&J’s immunology drug portfolio and a key driver of top-line growth. The drug generated sales of $1.7 billion in the first half of 2024, up 29% 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.
JNJ Stock Performance
Year to date, J&J’s shares have moved up 5.1% compared with the industry’s 24.2% rise.
Image Source: Zacks Investment Research
Competition in the IBD Space
The targeted market in the IBD space is highly competitive. A key player in this space is AbbVie (ABBV - Free Report) , 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 across multiple immunology indications, including UC, CD and PsA.
Another pharma giant that made its foray into the IBD space is Eli Lilly (LLY - Free Report) , following the FDA approval of Omvoh in UC indication last year in October. 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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JNJ Zacks Rank
J&J currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.