EMA’s CHMP Recommends New Uses for J&J’s Stelara and SimponiBy
Janssen-Cilag International NV reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval for the use of Stelara (ustekinumab), for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Based on the CHMP’s positive opinion, a final decision from the European Commission is expected during the third quarter of 2015. If approved, Stelera will become available for the treatment of adolescents from the age of 12 years and older living with moderate to severe plaque psoriasis, a chronic autoimmune disease that affects from 0.5 to 2% of the general population during childhood and adolescence.
Stelara, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies,including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA). Stelara is also approved alone or in combination with MTX, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.The Janssen Pharmaceutical Companies maintain exclusive worldwide marketing rights to Stelara, which is currently approved for the treatment of moderate to severe plaque psoriasis in 84 countries and psoriatic arthritis in 55 countries.
In other news, Janssen Biologics B.V. reported that EMA’s CHMP has adopted a positive opinion recommending approval for the use of subcutaneous Simponi (golimumab) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Based on the CHMP’s positive opinion, a final decision from the European Commission is expected during the third quarter of 2015. If approved, Simponit will become available for the treatment of patients with severe active nr-AxSpA, a form of spondyloarthritisâ€”chronic inflammatory diseases affecting the spineâ€”in which the predominant symptom is back pain and stiffness. It is estimated that 0.3 to 2.5% of the European population are affected by some type of spondyloarthritis.
Simponi 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. Simponi is approved in 85 countries for rheumatologic indications, including the EU, where Simponi received European Commission approval in October 2009 for the treatment of moderate-to-severe, active rheumatoid arthritis 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, Simponi received European Commission approval for the treatment of moderately to severely active ulcerative colitis. 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, Inc. licenses distribution rights to Simponi to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.