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J&J seeks US FDA approval for expanded use of skin disease drug Tremfya

Johnson & Johnson unit Janssen Pharmaceutical Cos. applied to the U.S. Food and Drug Administration for the use of Tremfya in treating adults with active psoriatic arthritis.

Active psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a condition characterized by red patches of skin topped with silvery scales. This type of arthritis often starts between ages 30 and 50, or about 10 years after psoriasis begins, according to the National Psoriasis Foundation.

About 30% of people with psoriasis have active psoriatic arthritis. There is no cure for the disease yet.

Tremfya, or guselkumab, aims to treat active psoriatic arthritis by selectively inhibiting the p19 subunit of interleukin-23, an important driver of psoriatic arthritis. The supplemental biologics license application is based on phase 3 studies dubbed Discover-1 and Discover-2, both of which met their main goals of improving patients' conditions.

J&J said it also plans to submit a marketing application to the European Medicines Agency for Tremfya in the active psoriatic arthritis indication by the end of 2019.

Tremfya has received regulatory nods from the U.S., Canada, the EU and several other countries to treat plaque psoriasis and in Japan to treat psoriasis, psoriatic arthritis and a chronic skin condition called palmoplantar pustulosis.