October 21, 2020 /
BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of an expanded indication for Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who are candidates for systemic therapy. In the European Union, Tremfya was first approved in November 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Tremfya is a monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine and a key driver in the pathogenesis of inflammatory diseases such as psoriasis and psoriatic arthritis (PsA).
Psoriatic arthritis (PsA) is a chronic, progressive disease characterized by joint pain and skin inflammation. Clinical studies have demonstrated that, compared with placebo, Tremfya significantly improved the symptoms and signs of joints, skin, and soft tissues in patients with active PsA. If approved, Tremfya will become the first selective IL-23 p19 subunit inhibitor in the European Union indicated for the simultaneous treatment of PsA and moderate-to-severe plaque psoriasis.
In the United States, Tremfya was first approved in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis. In July 2020, Tremfya was approved for the treatment of adult patients with active psoriatic arthritis (PsA). Notably, Tremfya is the first interleukin-23 (IL-23) selective inhibitor approved for the treatment of active PsA, and it remains the only biologic agent approved for active PsA whose product labeling indicates improvement in patient fatigue symptoms as assessed by the FACIT-F scale. Regarding administration, Tremfya is administered via subcutaneous injection at a dose of 100 mg, with a dosing regimen consisting of initial doses at weeks 0 and 4, followed by maintenance doses every 8 weeks thereafter. Tremfya may be used as monotherapy or in combination with conventional disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.
Psoriatic Arthritis (Image source: onhealth.com)
The CHMP’s positive opinion is based on data from two Phase III clinical studies (DISCOVER-1 and DISCOVER-2). Both studies evaluated the efficacy and safety of Tremfya versus placebo. The DISCOVER-1 study included patients who were either biologic-naïve (had not previously received biologic therapy) or had received anti-
Tumorpatients treated with tumor necrosis factor-alpha (TNF-α) biologics. The DISCOVER-2 study included only biologic-naïve patients and also assessed radiographic progression of joint damage. In both studies, patients were randomized to receive Tremfya 100 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) for 52 weeks; patients receiving placebo crossed over to Tremfya Q4W treatment at Week 24 through Week 52.
The 24-week results from two studies were published in April this year in The Lancet, a top-tier international medical journal. The results showed that both studies met their primary endpoints: after 24 weeks of treatment, a significantly higher proportion of patients in the Tremfya group achieved at least a 20% improvement in disease signs and symptoms (ACR20 response) compared to the placebo group. Specifically, in the two studies, the proportions of patients achieving an ACR20 response in the Tremfya groups were 52% and 64%, respectively, versus 22% and 33% in the placebo groups.
Furthermore, in two studies, the Tremfya treatment group demonstrated significant improvements over the placebo group across multiple secondary endpoints, including joint symptoms, skin symptoms, soft tissue inflammation and disease activity, physical function, and health-related quality of life. Assessed by the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) scale, Tremfya also improved fatigue symptoms in patients. The overall safety profile observed in patients with psoriatic arthritis (PsA) was generally consistent with that in patients with plaque psoriasis, with the occurrence of bronchitis and decreased neutrophil counts.
Tremfya is a human monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), and it is the first approved selective IL-23 inhibitor. IL-23 is a cytokine involved in multiple
Autoimmunityplayed a key role in the treatment of inflammatory diseases. Currently, Tremfya is also being developed for other
AutoimmunityTreatment of inflammatory diseases, including Crohn's disease (Phase IIb/III), ulcerative colitis (Phase IIb/III), and hidradenitis suppurativa (Phase II).
To date, Tremfya has been approved in multiple countries and regions worldwide for the treatment of adult patients with moderate to severe plaque psoriasis. In China, Tremfya (Tremfya) was approved for marketing in Hong Kong in November 2018; it was submitted for approval in mainland China in late June 2019 and received approval from the National Medical Products Administration (NMPA) of China in December 2019 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Notably, Tremfya was included in the “First Batch of Overseas New Drugs Urgently Needed for Clinical Use” released by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), with therapeutic indications covering erythrodermic psoriasis, plaque psoriasis, pustular psoriasis, psoriatic arthritis, and psoriasis vulgaris. The NMPA expedited the approval of Tremfya’s market launch through the priority review and approval pathway. (Bioon.com)
Original Source: Janssen Receives CHMP Positive Opinion for Expanded Use of TREMFYA?▼ (guselkumab) in the Treatment of Active Psoriatic Arthritis (PsA) in the European Union (EU)
