Media Release Planegg/Munich, Germany, July 14, 2020
MorphoSys’s Licensee Janssen Announces Approval of Tremfya® (Guselkumab) by U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) announced today that its licensee Janssen Research & Development, LLC (Janssen) announced the U.S. Food and Drug Administration (FDA) approval of Tremfya® (guselkumab) as a treatment for adult patients living with active psoriatic arthritis (PsA). Active PsA is a chronic progressive disease characterized by painful joints and skin inflammation. As Janssen announced, the approval of Tremfya® was based on results from the Phase 3 studies DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of Tremfya® in adults with active PsA compared to placebo. The results showed that a significant percentage of patients reached the studies’ primary endpoint of ACR20 at 24 weeks of treatment, with 52 to 64% of patients achieving an ACR20 response across the two trials. Dr. Malte Peters, Chief Research and Development Officer of MorphoSys, said: “Active psoriatic arthritis is a high burden for patients, causing limited mobility, pain and fatigue. We are very pleased about the FDA approval for Tremfya®, providing patients with a new treatment option for this debilitating indication.” Developed by Janssen, Tremfya® is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. It was generated utilizing MorphoSys’ proprietary HuCAL® antibody technology. In 2017, Tremfya® became the first drug based on MorphoSys’ antibody technology to receive regulatory approval for the treatment of plaque psoriasis. Tremfya® has been approved in the U.S., Canada, the European Union, and several other countries for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light), and in Japan for the treatment of various forms of psoriasis, psoriatic arthritis, and palmoplantar pustulosis. Guselkumab 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 receive certain milestone payments and receives royalties on net sales of Tremfya®.
More information about Tremfya® clinical studies is available on clinicaltrials.gov.