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J&J's Tremfya approved, further crowding IL-inhibitor market

The Food and Drug Administration on Thursday approved Johnson & Johnson's latest psoriasis treatment, bringing another player into the increasingly crowded market of interleukin (IL) inhibiting drugs.

Tremfya (guselkumab) received the green light for adults with moderate to severe plaque psoriasis. Regulators based their decision on efficacy and safety data from three late-stage trials that collectively enrolled more than 2000 patients and tested the drug against either AbbVie's Humira (adalimumab) or another Johnson & Johnson med, Stelara (ustekinumab).

Plaque psoriasis is an autoimmune disease characterized by red, scaley or itchy skin lesions. Like Stelara, Tremfya works by blocking interluekins, a class of proteins that regulate immune system responses. Other large pharmas, including Novartis, Eli Lilly, Sanofi and Regeneron, also have IL-inhibiting products on the market.

Dive Insight:

Johnson & Johnson knows all too well the benefits of IL-inhibitors, and not just from the patient perspective. Stelara, for instance, first received FDA approval in 2009 as a treatment for adults with moderate to severe psoriasis. In subsequent years, the drug racked up indications for active psoriatic arthritis and moderately to severely active Crohn's disease. In 2016, it raked in more than $3.2 billion for its parent.

The class has been fruitful for rival drugmakers as well.

Novartis' Cosentyx (secukinumab), which inhibits an interleukin known as IL-17A, also hit blockbuster status last year, with $1.13 billion in net sales. Lilly, meanwhile, received the go-ahead to market Taltz (ixekizumab) in March 2016. By year's end, it had generated $113 million of revenue.

Even though Stelara doesn't go off patent in the U.S. until 2023, Johnson & Johnson has been eager to flesh out its immunology pipeline and portfolio as of late. That urgency is likely due to biosimilar threats to the company's Remicade (infliximab) franchise, which has brought in roughly $6.5 billion to $7 billion annually since 2014.

Though Johnson & Johnson likely has some time before copycat biologics start to really erode its bottom lines, the company doesn't appear to be taking the matter lightly. In May, Janssen grabbed exclusive, worldwide, co-development and marketing rights to Protagonist Therapeutics' PTG-200, an oral inhibitor of IL-23, in a deal could be worth northwards of $1 billion.

What's more, the big drugmaker used a priority review voucher — a rare, highly valued asset the biopharma industry uses to get faster approval decisions from the FDA — on Tremfya, according to a July 13 statement from Janssen, Johnson & Johnson's research arm.

"Addressing the need for additional safe and effective plaque psoriasis therapies has been a critical area of focus at Janssen for more than 15 years," Andrew Greenspan, Janssen's vice president of medical affairs, said in the statement. "Considering this, we applied a priority review voucher to the application for Tremfya to bring this novel treatment to patients sooner."

The main obstacle now for Tremfya is differentiating itself from other IL-targeting drugs. The new treatment inhibits is an IL-23 inhibitor, pitting it directly against Stelara, an IL-12/IL-23 blocker. Fortunately, results from the Phase 3 NAVIGATE trial showed patients who didn't adequately respond to Stelara treatment who then switched to Tremfya therapy developed significantly improved skin clearance compared to those who only received the older drug.

J&J is currently enrolling a Phase 3 head-to-head trial to study Tremfya, which targets IL-23, vs. Cosentyx, which targets IL-17A, in the treatment of moderate to severe plaque psoriasis. Tremfya is approved for psoriasis like the other IL-17 agents.  Although Cosentyx, Taltz (IL-17A) and Siliq (IL-17R), which target the IL-17 pathway, have warnings in their US labels regarding inflammatory bowel disease (IBD) and potential for exacerbations. J&J is moving forward with plans to study Tremfya in Crohn’s disease, in addition to an ongoing Phase 3 study evaluating Tremfya in psoriatic arthritis.

J&J licensed the HuCal antibody library technology to generate the guselkumab antibody from Morphosys. The big drugmaker developed guselkumab internally and will exclusively commercialize the product.  from: biopharmadive.com


15/07/2017 - Categoria: Farmaci - Da: Sh@wn - 1433 letture



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