FDA approves Tremfya to treat psoriatic arthritis.-Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA.

The safety and efficacy of Tremfya in PsA have been demonstrated in two pivotal Phase III clinical trials. Tremfya is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. Tremfya can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD (e.g., methotrexate).