Johnson & Johnson JNJ announced that it has filed two supplemental biologics license applications (sBLA) seeking expanded use of its drug Tremfya in pediatric patients.
While one sBLA seeks approval of Tremfya for treating children 6 years and older with moderate-to-severe plaque psoriasis (PsO), the other one is for children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).
Tremfya, an IL-23 inhibitor, is already approved to treat certain adult patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU.
The PsO sBLA is based on data from the phase III PROTOSTAR study in pediatric patients and bridging pharmacokinetic (PK) data from the phase III VOYAGE 1 and 2 studies in adult PsO patients. The filing for jPsA is based on PK extrapolation analyses from adult PsA studies, DISCOVER 1 and 2, and efficacy and safety data from the PROTOSTAR study.
So far this year, J&J’s shares have declined 1.3% against the industry’s 8.8% increase.
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Tremfya is a Key Top-Line Driver for JNJ
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 $2.7 billion in the first nine months of 2024, up 21.6% year over year, driven by strong market growth and share gains.
Though the approval of Tremfya for psoriasis and psoriatic arthritis indications in kids will contribute to sales growth, the key to Tremfya’s growth is its approval for inflammatory bowel disease (IBD) conditions, ulcerative colitis (“UC”) and Crohn’s disease (“CD”).
Tremfya in IBD Conditions
Tremfya was approved by the FDA for moderately to severely active UC in September this year. Tremfya is also under review in the EU for UC. Tremfya is under review in the United States and EU for the other IBD condition, CD.
J&J expects Tremfya to be a $5 billion product with approvals in IBD conditions.
Competition in the IBD Space
In recent years, there has been a surge in the prevalence of gastrointestinal disorders like UC and CD 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 with novel mechanisms of action to help patients with UC and CV achieve long-term clinical remission. Some other key players in the IBD market are AbbVie ABBV, Eli Lilly LLY, Pfizer, Novartis, Merck MRK, 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.
AbbVie expects sales of its key immunology drugs, Skyrizi and Rinvoq in IBD indications to double in 2024. In 2024, AbbVie 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.
Lilly’s new drug Omvoh was approved for UC in the United States, Europe and Japan in 2023. For CD, Lilly filed regulatory applications in the United States, Europe and Japan in 2024. This year Lilly also acquired small biotech Morphic Therapeutics whose lead pipeline candidate is MORF-057, in mid-stage development for both UC and CD.
In 2023, Merck acquired small biotech Prometheus Biosciences, which added tulisokibart/MK-7240 to its pipeline. MK-7240, a novel TL1A inhibitor, is being developed in phase III for UC.
In 2023, Roche acquired Telavant, including rights to the novel TL1A-directed antibody (RVT-3101) from Roivant for the treatment of IBD conditions.
In October 2023, Sanofi in-licensed rights to jointly develop and commercialize Teva Pharmaceutical’s IBD candidate, TEV’574, an anti-TL1A therapy. TTEV’574 is being evaluated in a phase IIb study for UC and CD.
J&J’s Zacks Rank
Johnson & Johnson Price and Consensus
Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote
J&J currently has 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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