Centocor Ortho Biotech Inc. has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand the Simponi physician label. The sBLA includes inhibition of the progression of structural damage and maintenance of improvement in signs and symptoms and physical function in the treatment of patients with active Psoriatic Arthritis (PsA).
This submission represents the second sBLA submission for Simponi in 2010. In September 2010, Centocor Ortho Biotech submitted a sBLA seeking to expand the Simponi label to include the inhibition of the progression of structural damage in the treatment of moderately to severely active Rheumatoid Arthritis (RA). In April 2009, Simponi received US FDA approval as the first once-monthly Anti-Tumour Necrosis Factor (TNF)-alpha therapy for the treatment of adults with moderately to severely active RA, active PsA, and active Ankylosing Spondylitis (AS).
“This application seeks to expand the Simponi label to include inhibiting the progression of structural damage, a potentially devastating manifestation sometimes associated with active psoriatic arthritis," said Jerome A. Boscia, MD, senior vice president, Clinical R&D, Centocor Research & Development, Inc. “This marks an important clinical milestone in the continued lifecycle development of Simponi” he added.
The sBLA is supported by data from the (Golimumab – A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody) GO-REVEAL study, which evaluated the safety and efficacy of Simponi in patients with active PsA. Psoriatic arthritis is a chronic inflammatory disease that causes joint pain and swelling, skin symptoms and can lead to joint destruction.
Simponi is a human monoclonal antibody that targets and neutralizes excess 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. A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the US, Europe and Canada, Simponi is approved for the treatment of moderately to severely active RA in combination with methotrexate, active PsA and active AS.
Centocor Ortho Biotech Inc. discovered and developed Simponi and has exclusive marketing rights to the product in the US.
Simponi (golimumab) is a prescription medicine and can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting simponi and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start Simponi if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or has diabetes, HIV or a weak immune system and also if you are currently being treated for an infection or if you have or develop any signs of an infection such as: fever, sweat, or chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhoea or stomach pain, burning when you urinate or urinate more than normal and feel very tired
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including Simponi, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancer and all about the medications you are taking including Orencia (abatacept), Kineret (anakinra), Rituxan (rituximab) or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking Simponi should not receive live vaccines.
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as Simponi. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with Simponi. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as: feel very tired, skin or eyes look yellow, little or no appetite, vomiting, muscle aches, dark urine, clay-coloured bowel movements, fevers, chills, stomach discomfort and skin rash
Heart failure can occur or get worse in people who use TNF blockers, including Simponi. Your doctor will closely monitor you if you have heart failure and tell them if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.
Rarely, people using TNF blockers, including Simponi, can have nervous system problems such as multiple sclerosis and if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body contact your physician.
Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF blockers, including Simponi. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment contact if you have signs such as fever, bruising, bleeding easily, or paleness.
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber. Tell your doctor if you have any symptoms of an allergic reaction while taking Simponi such as hives, swollen face, breathing trouble, chest pain.
Common side effects of Simponi include: upper respiratory tract infection, nausea, abnormal liver tests, skin reaction at site of injection, high blood pressure, flu, and cold sores.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology. The company was created when Ortho Biotech Inc. merged into Centocor, Inc., and it was renamed Centocor Ortho Biotech Inc. It harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options.