J&J's IL-23 Inhibitor Tremfya Receives FDA Approval for Ulcerative Colitis, Marking First-in-Class Dual-Mechanism Therapy

Johnson & Johnson Launches Aggressive Push in IBD (Inflammatory Bowel Disease) Field, Submits Two FDA Applications for Market Approval Within a Year.

In March this year, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA for its product Tremfya (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

Another time in June this year, Johnson & Johnson submitted an sBLA to the FDA for Tremfya to treat adult patients with moderately to severely active Crohn's disease (CD).

Now, three more months have passed, and Tremfya has secured its first IBD indication.

On September 11, 2024, Johnson & Johnson announced that Tremfya received FDA approval for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

The press release shows that Tremfya isCurrently the first and only fully human dual-action monoclonal antibody for UC treatment,Can block IL-23 while binding to the CD64 receptor.

"Tremfya significantly improved chronic symptoms caused by ulcerative colitis, particularly helping restore the endoscopic appearance of the intestinal mucosa to normal," said Dr. David T. Rubin, Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine and Chief Investigator of the QUASAR study.

The approval of the UC indication this time was supported by the ongoingKeySupported by data from the Phase 2b/3 QUASAR study.This study aims to evaluate the safety and efficacy of Tremfya as a later-line treatment for adult patients with moderate to severe active UC who have had an inadequate response or intolerance to conventional therapies, other biologics, or JAK inhibitors.

The results show that,At Week 44,50% received Tremfya 200mg subcutaneous (SC) maintenance treatment every 4Patients receiving Tremfya 100mg SC every 4 weeks (q4w) and 45% of patients receiving Tremfya 100mg SC every 8 weeks (q8w) achieved the primary endpoint of clinical remission, compared to 19% in the placebo group (p<0.001).

In addition,After receiving one year of Tremfya SC maintenance treatment,34% of the 200mg group and 35% of the 100mg group achieved endoscopic remission, compared to 15% in the placebo group (p<0.001).

The reason for establishment200mg and100 mg in two dosage groups, becauseTremfya is available in both subcutaneous (SC) and intravenous (IV) formulations.200mg IV as the induction dose for the first eight weeks, followed by two recommended maintenance doses: 100mg SC at week 16, then q8w; 200mg SC at week 12, then q4w.

Currently,TremfyaGlobally, it has been approved for four indications, with the other three beingModerate to Severe Plaque Psoriasis (July 2017),Active Psoriatic Arthritis (July 2020) andPalmoplantar Pustulosis (Approved only in Japan).

Johnson & Johnson's eagerness to aggressively pursue the IBD field is mainly driven by two factors: its own pipeline and market demand.

In terms of its own pipeline, Johnson & Johnson is undoubtedly the "big brother" in the IBD field. The first anti-TNF drug for CD, infliximab (Remicade), and the first IL-23 antibody for CD, ustekinumab (Stelara), were both developed by Johnson & Johnson.

But now, since Remicade was first launched in 1998, its peak has long passed; the U.S. patent for Stelara expired last year.According to statistics from the Pharma ONE database, a total of 78 companies worldwide are involved.StelaraResearch on biosimilars, of which 8 have been approved for marketing, 3 are in the marketing application stage, and 24 have entered phase III clinical trials.

In addition to continuously expanding new indications for Stelara, Johnson & Johnson urgently needs a new drug to take over the baton and support its own autoimmune portfolio.

In terms of market demand, let's first talk about Johnson & Johnson's autoimmune products. In 2014, Remicade's sales peaked at nearly $9 billion; Stelara's sales exceeded $10 billion last year, reaching $10.858 billion.IBD business is the top priority among these blockbuster products.

Global Market. According to incomplete statistics, the current global IBD market is approximately 18 billion USD, and it is expected to grow to about 49 billion USD globally by 2030.

It is worth mentioning that the IBD market is highly concentrated and characterized by frequent iterations. According to statistics, four treatment products, including adalimumab, account for 75% of global revenue.(Humira $14.404 billion, Dupixent $11.588 billion, Stelara $10.858 billion, and Skyrizi $7.763 billion).

As for frequent iterations. Approximately one-third of IBD patients do not respond to biologic therapies; among those who initially respond to treatment, about half will experience "secondary loss of response," indicating a significant market demand.

In response, Johnson & Johnson has placed a strong emphasis on the new-generation IL-23 monoclonal antibody Tremfya, with the IBD field becoming the preferred choice after psoriasis. Not only that, but Johnson & Johnson has also developed an oral formulation of the IL-23 antibody JNJ-2113 for the treatment of IBD, as well as a combination drug JNJ-8408 (Tremfya + TNF drug golimumab) targeting patients with relapses.

It can be said that,Johnson & Johnson hasBuilding up the next few decadesIBD FieldCompetitive pipeline layout.

In June this year, AbbVie's IL-23 inhibitor Skyrizi was approved by the FDA for moderate to severe UC, becoming the world's first IL-23 antibody used for IBD treatment.

Therefore, Johnson & Johnson can only claim in its press release that Tremfya is currently the first and only fully human dual-action monoclonal antibody for the treatment of UC.

The old king of drugs, Humira, has seen a significant decline in sales since losing its market exclusivity, with revenue dropping to $14.4 billion in 2023, a year-on-year decrease of 32%. In addition, numerous blockbuster drugs such as Dupixent, Entyvio, Rinvoq, Tremfya, and Ultomiris, including even super blockbusters with revenues exceeding $10 billion, will lose core patent protection within the next five years.

Whether it's Johnson & Johnson, AbbVie, or Sanofi, all are eager to seize this golden window of opportunity, leveraging the PIP characteristics of autoimmune drugs to rapidly advance new drug iterations.

Currently, ongoing trials for Tremfya include pediatric ulcerative colitis, juvenile psoriatic arthritis, pediatric Crohn's disease, subcutaneous induction for ulcerative colitis, structural damage in psoriatic arthritis, and pediatric psoriasis.

Perhaps in the near future, autoimmune drugs will return to the battle for the title of top-selling drug.

Cover image source: pixabay

The Largest Financing in Biotech This Year is Born! Who Will Be the Next "Buyer"?

Novo Nordisk China R&D Day: Envisioning a Future Without Severe Chronic Diseases / Star Start 2024 Winners Announced

Head-to-Head Drug King, Great Victory!

Come to the PharmaTimes official website, discover the treasure! ~~