"We are pleased to present the
The BLA is supported by findings from the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER) trial, which evaluated the safety and efficacy of intravenously administered SIMPONI, in combination with methotrexate, via a 30-minute infusion at weeks 0, 4 and then every eight weeks compared with placebo in 592 adults. Study participants had been diagnosed with active RA, defined as having at least six tender and six swollen joints, and had been receiving background methotrexate for at least three months. The primary endpoint of GO-FURTHER is the proportion of patients demonstrating 20 percent improvement in arthritis signs and symptoms (ACR 20) at week 14. Secondary endpoints include a 50 percent improvement in arthritis signs and symptoms (ACR50) at week 24, improvements in disease activity and physical function, as measured by the European League Against Rheumatism (EULAR)/Disease Activity Score (DAS) 28-C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ), and inhibition of structural damage, as measured by X-ray.
Week 24 signs and symptoms, physical function and safety results from the Janssen R&D-sponsored study were presented at the 2012 EULAR Annual Congress and the study appeared in the
An application requesting approval of an intravenous formulation of SIMPONI for the treatment of moderately to severely active RA is currently under review in the
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability. It is estimated that 1.5 million Americans and more than 23.5 million people worldwide are affected by the condition, for which there is no cure.
About SIMPONI Subcutaneous Formulation
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. SIMPONI is approved in 57 countries for adult rheumatologic indications, including
Applications seeking approval for SIMPONI as a subcutaneously administered anti-TNF-alpha therapy have been submitted in the EU and U.S. seeking approval for the treatment of adult patients with moderately to severely active ulcerative colitis.
SIMPONI is also being investigated in Phase 3 studies as a subcutaneously administered treatment for active polyarticular juvenile idiopathic arthritis (JIA).
The U.S. full prescribing information for SIMPONI can be accessed at the following link: http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.
For further information about SIMPONI outside of
Important Safety Information About SIMPONI Subcutaneous Formulation
SIMPONI® (golimumab) is a prescription medicine. SIMPONI® 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. Tell your doctor if you have been in a region (such as the
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 have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
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 cancers.
Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), 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 should 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:
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. Tell your doctor right away 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 or Guillain-Barre syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
Serious liver problems can happen in people using TNF blockers, including SIMPONI®. 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. Tell your doctor 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 pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI® during pregnancy. Tell your baby's doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.
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. Some reactions can be serious and life-threatening.
Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.
Please read the Medication Guide for SIMPONI® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the
The U.S. full prescribing information for SIMPONI® can be accessed at the following link: http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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