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J&J files for expanded use of psoriasis drug Tremfya in EU

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J&J files for expanded use of psoriasis drug Tremfya in EU

Johnson & Johnson filed an application with the European Medicines Agency seeking approval for expanded use of its medicine Tremfya to treat adult patients with active psoriatic arthritis.

Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis — a condition that features red patches of skin topped with silvery scales. Symptoms of psoriatic arthritis include joint pain, stiffness and swelling. It is estimated that up to a third of the 14 million people living with psoriasis in Europe will also develop psoriatic arthritis, J&J said in an Oct. 23 press release.

Tremfya, or guselkumab, works by selectively inhibiting the p19 subunit of interleukin-23 protein and gene, which plays a role in the growth of the disease. J&J said if Tremfya is approved, it will become the first medicine of its kind in the EU to treat active psoriatic arthritis.

J&J said the submission was backed by positive data from two phase 3 studies — Discover-1 and Discover-2. The company has already applied with the U.S. Food and Drug Administration for the expanded use of Tremfya for the same indication.

Tremfya is approved in the U.S., EU, Canada, and several other countries to treat plaque psoriasis and in Japan to treat psoriasis, psoriatic arthritis and a chronic skin condition called palmoplantar pustulosis.