Johnson & Johnson is battling giants in the immunology field with its IL-23 inhibitor Tremfya. With other next-gen drugs already crowding the market, J&J now has the FDA's nod to take Tremfya into psoriatic arthritis in what could prove to be a tough challenge.
The FDA on Tuesday approved J&J's Tremfya as the first IL-23 inhibitor to treat psoriatic arthritis, which affects around 1.5 million Americans each year, the drugmaker said.
The agency based its review on data from two pivotal phase 3 trials showing Tremfya topped placebo in the number of psoriatic arthritis patients who showed 20% improvement in disease symptoms at the 24-week mark.
In the two studies from J&J's Discover program, 58% of patients were also treated with immunosuppressant methotrexate. One of the studies only included patients who had not been previously treated with a biologic while the other enrolled 31% of patients who had previously been treated with an anti-TNF drug.
Tremfya is administered under the skin in eight-week intervals after patients receive starter doses at the initiation of treatment and the four-week mark, J&J said.
