Janssen seeks EMA approval for Tremfya for PsA

Janssen has applied to extend the use of its immunology therapy Tremfya (guselkumab) for psoriatic arthritis (PsA) in Europe, on the back of results from two phase 3 trials, DISCOVER-1 and DISCOVER-2, that met the primary endpoint of a 20% improvement in PsA symptoms (ACR 20 response) at week 24. The antibody also improved several secondary measures, including ACR 50 and ACR 70 responses and showed signs that it could improve physical function in PsA patients. Tremfya has FDA approval for psoriasis and an application was submitted to the FDA for psoriatic arthritis approval in September. If this EMA filing is approved, Tremfya will be the first selective IL-23 inhibitor for people with active PsA in Europe.
Alyssa Johnsen, Janssen research & development vice-president and rheumatology disease area leader, said: “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. With this filing, we hope to offer clinicians a new and innovative treatment option for people living with psoriatic arthritis.”