Johnson & Johnson (J&J) has announced that it is seeking US Food and Drug Administration (FDA) approval to include new evidence for Tremfya (guselkumab) in psoriatic arthritis (PsA).
The company has filed an application with the regulator to include new evidence in the drug’s label for the inhibition of progression of structural damage in adults with active PsA.
Approximately 125 million people globally are living with some form of psoriasis, a chronic inflammatory condition that typically affects the skin, nails and joints.
Around 30% of psoriasis patients are affected by PsA, which causes pain, stiffness and swelling in and around the joints and commonly appears in those aged between 30 and 50 years.
Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and bind to the CD64 receptor. The drug is already approved in the US to treat certain cases of active PsA, as well as plaque psoriasis, ulcerative colitis and Crohn’s disease.
The new submission is supported by data from the phase 3b APEX trial, which has been comparing Tremfya against placebo in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies.
The study met its primary endpoint, with Tremfya demonstrating a significant reduction in the signs and symptoms of the disease compared to placebo.
J&J’s drug also significantly reduced the progression of joint structural damage, a major secondary endpoint, as measured by change in the modified van der Heijde-Sharp score, at 24 weeks compared to placebo.
Brandee Pappalardo, vice president, medical affairs, dermatology and rheumatology, J&J Innovative Medicine, said: “PsA is a complex disease that can lead to severe and irreversible joint damage… With this new evidence, Tremfya would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA.”
The announcement comes just four months after Tremfya was approved by the FDA to treat adults with moderately to severely active Crohn’s disease, one of the two main forms of inflammatory bowel disease.