On 16 September, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) announced its submission of Tremfya (guselkumab) for approval by the US Food and Drug Administration (FDA) for patients with psoriatic arthritis (PSA).
This regulatory filing is based on results from the Phase 3 DISCOVER-1 and DISCOVER-2 studies. Both pivotal trials met their primary endpoints of joint symptom improvement as assessed by the American College of Rheumatology (ACR) 20 criteria. Janssen is also expected to submit a marketing application for Tremfya to the European Medicines Agency (EMA) by the end of this year.
Tremfya is already approved in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) for psoriasis (PSO), and was approved for PsA in Japan in April 2018.
If approved by the FDA, Tremfya would be the first selective interleukin (IL)-23 inhibitor on the PsA market, competing with SunPharma’s tildrakizumab. The only other non-selective IL-23 inhibitor currently approved in the US is Johnson & Johnson’s Stelara (ustekinumab). Due to Johnson & Johnson’s extensive experience in the space from marketing both Remicade (infliximab) and Stelara (ustekinumab), GlobalData believes that Tremfya will see a strong uptake in the years to come.
Tremfya seemed to be squarely in the middle of the field based on the mixed efficacy results of head-to-head psoriasis comparator trials with other biologic therapies. Most recently, Tremfya was proven to be inferior to Eli Lilly’s Taltz (ixekizumab), an IL-17 inhibitor, in skin clearance during the IXORA-R trial. Improvement in patients with moderate to severe psoriasis was assessed using the PASI100 at 12 weeks. However, Tremfya was previously shown to be superior to Novartis’ Cosentyx (secukinumab), also an IL-17 inhibitor, based on the results of the ECLIPSE trial (measuring PASI90 in PsO patients), as well as superior to AbbVie’s Humira, measured by the PASI90 in the pivotal VOYAGE-2 trial in PsO patients, as assessed by the PASI90.
Comparator studies pitting Tremfya against either of J&J’s existing PsA drugs, the IL-12/23 inhibitor Stelara (ustekinumab) or the tumour necrosis factor (TNF) inhibitor Remicade (infliximab), have yet to be completed. Tremfya appears to have comparable safety to the IL-17 inhibitors based on available data in psoriasis. The Tremfya label currently carries warnings for increased risk of infection and tuberculosis (TB). However, it carries fewer risks compared to Stelara, which notes the additional risks of certain serious bacterial infections, malignancies, hypersensitivities, and reversible posterior leukoencephalopathy syndrome (RPLS) on its label.
Key opinion leaders interviewed by GlobalData noted that Tremfya has a slight advantage over the IL-17 inhibitor class, as it can be used if patients have a history of Crohn’s disease—a contraindication of the IL-17 inhibitors.
With this regulatory submission completed, GlobalData expects Tremfya to launch within the next year. Its most recent trial results have solidified the drug as a strong contender in an ever-growing list of biologic therapies. Although additional head-to-head trials are necessary to definitively assess its standing compared to other available therapeutics within PsA, Tremfya is notable in several ways. Being the first selective IL-23 inhibitor approved for PsA will likely give it a competitive edge in marketing. Additionally, Tremfya is only administered every eight weeks, which could make it an attractive option for patients, especially compared to dosing every four weeks or multiple times per week for other biologics. With Stelara’s patents set to expire between 2023 and 2026 in the 7MM, and the global launch of infliximab biosimilars and a TNF inhibitor, Tremfya is poised to take its place and help Johnson & Johnson maintain its PsA market share.