Insight on submission of USFDA sBLA of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)

MorphoSys AG, a clinical-stage biopharmaceutical company, announced that its licensee Janssen Research & Development, submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking approval of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).

As Janssen announced, the sBLA is based on results from the phase 3 studies DISCOVER-1 and DISCOVER-2, which met their primary endpoints of patients achieving an American College of Rheumatology 20 per cent improvement (ACR20) response after 24 weeks of treatment. According to Janssen, the safety profile observed for Tremfya in the DISCOVER studies was generally consistent with previous studies as well as the current Tremfya prescribing information. The DISCOVER program comprises the first phase 3 studies evaluating a human monoclonal antibody against the p19 subunit of interleukin (IL)-23 for active PsA, and the results have been submitted for presentation at an upcoming medical meeting, as Janssen stated.

Tremfya is a human monoclonal antibody against the p19 subunit of IL-23 developed by Janssen that was generated utilizing MorphoSys’s proprietary HuCAL antibody technology.

According to Janssen, the company expects to submit a marketing application to the European Medicines Agency seeking approval of Tremfya as a treatment for PsA before the end of the year. Tremfya has been approved in the US, Canada, the European Union, and several other countries for the treatment of plaque psoriasis and in Japan for the treatment of various forms of psoriasis, psoriatic arthritis, and palmoplantar pustulosis. Tremfya is currently being investigated in clinical studies in several indications, including additional studies in plaque psoriasis, pediatric psoriasis, psoriatic arthritis, Crohn’s disease, hidradenitis suppurativa, ulcerative colitis and familial adenomatous polyposis. MorphoSys is eligible to certain milestone payments and receives royalties on net sales of Tremfya.