J&J Progresses New Uses for Simponi and Imbruvica
Johnson & Johnson (J&J) reports developments for two of its drug, Simponi (golimumab) and Imbruvica (ibrutinib).
In the first development, the European Commission (EC) has approved J&J’s Janssen Biologics’s Simponi for the treatment of polyarticular juvenile idiopathic arthritis (pJIA). Simponi in combination with methotrexate (MTX) is approved for use in children with a body weight of at least 40 kg and who have responded inadequately to previous treatment with MTX. The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2016 recommending the use of Simponi for pJIA, the most common type of arthritis in children under the age of 17 in which the predominant symptoms are persistent joint pain, swelling and stiffness.
Simpoini is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. It is approved in more than 85 countries for rheumatologic indications, including rheumatoid arthritis (RA), ankylosing spondylitis,and psoriatic arthritis. In the European Union (EU), SImponi received EC approval in October 2009 for the treatment of moderate-to-severe, active RA in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis. In September 2013, it eceived EC approval for the treatment of moderately to severely active ulcerative colitis in adults. In June 2015, Simponi received EC approval for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation. Simponi is available either through the SmartJect autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.
Janssen Biotech, Inc. discovered and developed Simponi and markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Janssen Biotech licenses distribution rights to Simpoini to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, Janssen Biotech licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.
In other news, the US. Food and Drug Administration (FDA) has granted a fourth breakthrough therapy designation for J&J’s Imbruvica (ibrutinib) as a monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy, The FDA also granted the therapy orphan drug designation (ODD) for cGVHD. GVHD is a life-threatening condition in which the body is attacked by donor immune cells after a patient undergoes an allogeneic stem cell or bone marrow transplantt. Imbruvica is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. ,