MorphoSys' Licensee Announces Approval by the European Commission for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA)
DGAP-News: MorphoSys AG
/ Key word(s): Miscellaneous
PLANEGG/MUNICH, Germany, December 2, 2020-MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC. (Janssen) reported the European Commission's approval for the use of Tremfya(R) (guselkumab) in the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
Developed and marketed by Janssen, Tremfya is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23-an important driver of the progression of inflammatory diseases1 and inhibits its interaction with the IL-23 receptor. It was generated utilizing MorphoSys' proprietary HuCAL(R) antibody technology and became the first drug based on MorphoSys' antibody technology to receive regulatory approval for the treatment of plaque psoriasis in 2017. Tremfya is currently approved in 76 countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy2, and in Brazil, Canada, Ecuador, Japan, Taiwan and the U.S. for the treatment of adult patients with active PsA.
"As a new, first-in-its-class treatment option for patients with psoriatic arthritis, Tremfya provides much-needed treatment opportunities to improve the lives of patients suffering from this debilitating disease", said Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "We are very pleased and extremely proud that Tremfya has been approved by the European Commission for the treatment of adult patients with active psoriatic arthritis in the European Union."
PsA is a multifaceted, chronic, immune-mediated, inflammatory disease that is progressive and irreversible. It is characterized by debilitating joint damage, inflammation, enthesitis, dactylitis, axial disease, and skin lesions generally associated with psoriasis. In addition, due to the stiffness and the painful swelling of the joints and the connective tissue, carrying out daily tasks can become difficult.3,4 There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA.5,6
As Janssen announced, the approval for this new indication is based on the results of Janssen's DISCOVER-1 and DISCOVER-2 Phase 3 clinical studies which assessed the safety and efficacy of guselkumab in adult patients with active PsA. In both studies, guselkumab was well-tolerated and observed adverse events (AEs) were generally consistent with previous studies of guselkumab and the current prescribing information.
The approval by the European Commission for Tremfya follows a CHMP positive opinion in October 2020 for treatment of adults with active psoriatic arthritis in the European Union (EU).
About the DISCOVER program
Monjuvi(R) and HuCAL(R) are registered trademarks of MorphoSys AG.
MorphoSys Forward-Looking Statements
1. Benson JM, et al. Discovery and Mechanism of Ustekinumab: A Human Monoclonal Antibody Targeting interleukin-12 and interleukin-23 for Treatment of Immune-Mediated Disorders. MAbs 2011;3:535-545.
2. European Medicines Agency. TREMFYA Summary of Product Characteristics. 2019. Available at: www.medicines.org.uk/emc/medicine/34321. Accessed September 2020.
3. Busse K, Liao W. Which Psoriasis Patients Develop Psoriatic Arthritis? Psoriasis Forum 2010;16(4):17-25.
4. Belasco J, Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther 2019;6(3):305-315.
5. Ogdie A and Weiss P. The Epidemiology Psoriatic Arthritis. Rheum Dis Clin North Am 2015;41(4):545-568
6. Ortonne JP and Prinz JC. Alefacept: A Novel and Selective Biologic Agent for the Treatment of Chronic Psoriasis. Eur J Dermatol 2004;14:41-45.
02.12.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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