TREMFYA ® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.[1],[2] 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 3 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).The Unmet Needs in PsAPsoriatic arthritis affects about 1.5 million Americans.[3] Studies show that up to 30 percent of the more than eight million Americans living with psoriasis will also develop PsA.[4] There is currently no cure for the disease and, despite available treatments, many people living with PsA are still searching for more options that can help alleviate their symptoms and provide some relief. Psoriatic arthritis is a chronic, progressive, immune-mediated disease characterized by joint inflammation, enthesitis (inflammation where the bone, te...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news