Janssen has submitted a type II variation application to European Medicines agency, looking to get approved guselkumab, which could then be the first selective IL-23 p19 subunit inhibitor for people in the European Union with active psoriatic arthritis.
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BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II Variation Application to the European Medicines Agency (EMA) seeking first-in-class approval of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA). If approved, this will be the second approved indication for guselkumab in the European Union.
Guselkumab is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23, which is an important driver of the pathogenesis of immune-mediated inflammatory diseases such as psoriasis and PsA.
It is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also develop PsA, a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any age.
“This submission to the EMA is an important milestone for people with psoriatic arthritis, who currently have limited treatment options that improve the signs and symptoms of the condition,” said Alyssa Johnsen, M.D. Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. “With this filing, we hope to offer clinicians a new and innovative treatment option for people living with psoriatic arthritis.”
This regulatory submission is based on data from the Phase 3 DISCOVER-1 and DISCOVER-2 studies. The DISCOVER programme comprises the first-ever Phase 3 studies evaluating a human monoclonal antibody targeting the p19 subunit of IL-23 in patients with active PsA, and the results have been submitted for presentation at an upcoming medical meeting.
“Psoriatic arthritis is a complex disease causing considerable distress to those afflicted and their families. It is believed to be caused by both genetic and environmental factors,” said Professor Iain McInnes, Muirhead Professor of Medicine and Director of the Institute of Infection Immunity and Inflammation, University of Glasgow. “Although treatment options for PsA have improved dramatically over the past 15 years, a significant unmet need still exists, with only half of patients achieving more than a 20 percent improvement in joint symptoms in randomised clinical trials. Moreover, too few patients enjoy an acceptable quality of life. New treatment options with different mechanisms of action are urgently needed to improve outcomes.”
Guselkumab was previously approved in the European Union for the treatment of adult patients with moderate to severe plaque psoriasis in November 2017 and has also been approved in the U.S., Canada, Japan and several other countries worldwide.
In the phase 2a study of guselkumab in PsA, guselkumab was generally well tolerated during approximately 1 year of exposure.7 The incidence of adverse events, including infections, was similar across both treatment groups. Few serious adverse events were reported, discontinuation was infrequent, and serious infections were rare. The safety outcomes in this phase 2a study were generally consistent with those observed in clinical trials investigating guselkumab in psoriasis.
During clinical development of guselkumab in psoriasis, guselkumab was generally well-tolerated. The very common and common adverse events associated with guselkumab are as follows: upper respiratory infection (very common, ≥1/10), and arthralgia, diarrhoea, gastroenteritis, headache, herpes simplex infections, injection site erythema, tinea infections and urticaria (common, ≥1/100 to <1/10). Injection site pain, hypersensitivity and rash have been reported as uncommon adverse events (≥1/1,000 to <1/100).