FDA OKs Anti-Inflammatory Drug Simponi for Rheumatoid Arthritis
Drug Is Approved to Treat RA, Psoriatic Arthritis, and Ankylosing Spondylitis|
"Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (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 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
By Michael W. Smith, MD
WebMD Health News
Reviewed by Louise Chang, MD
April 24, 2009 -- The FDA has approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.
"Today's approval provides another treatment option for patients with these three debilitating disorders," says Bob Rappaport, MD, director of the division of anesthesia, analgesia, and rheumatology products in the FDA's Center for Drug Evaluation and Research, in a news release. "And the steps we're taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class."
Simponi is injected under the skin. It is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.
In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.
Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (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.
Like other similar drugs, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. Other TNF blockers include Enbrel, Humira, and Remicade.
The FDA also required additional information, as it required for other TNF-alpha blockers. This includes a medication guide for patients and a communication plan to help prescribers understand the drug's risks.
The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.
FDA Approves Simponi
Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
HORSHAM, Pa., April 24 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi (golimumab) for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. Simponi is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy that offers an effective once-monthly treatment option. Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are chronic inflammatory diseases that result in pain and inflammation, and in some cases, joint destruction and disability. These diseases affect more than three million Americans combined.
"Simponi has been studied in a broad range of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis who had previously received a wide variety of treatments, including adults with rheumatoid arthritis previously treated with anti-TNF therapies, and has been shown to be significantly effective in reducing the signs and symptoms of each of these diseases," said Jonathan Kay, MD, Associate Clinical Professor of Medicine, Harvard Medical School and lead study investigator. "The approval of Simponi offers rheumatologists an effective new anti-TNF therapy for patients living with rheumatic diseases."
In the U.S., Simponi is approved as a 50 mg subcutaneous injection once a month and is indicated:
* In combination with methotrexate for the treatment of adult patients with moderately to severely active rheumatoid arthritis
* Alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis
* For the treatment of adult patients with active ankylosing spondylitis
Simponi is available in two dosage forms. The Simponi SmartJect is a novel autoinjector designed to meet the needs of arthritis patients that has received the Ease-of-Use Commendation by the Arthritis Foundation. Simponi is also available as an easy to use prefilled syringe.
The efficacy and safety of Simponi have been evaluated in one of the most comprehensive clinical development programs for an anti-TNF-alpha therapy, which included simultaneous studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The program, which includes more than 2,000 patients across five pivotal Phase 3 trials, served as the primary basis for FDA approval. In rheumatoid arthritis, Simponi has been studied in a broad range of patients, including adults naive to methotrexate, adults responding inadequately to methotrexate and adults previously treated with at least one anti-TNF-alpha agent. In each of the three trials, significantly more patients receiving Simponi 50 mg plus methotrexate achieved at least a 20 percent improvement in arthritis symptoms (ACR20), compared with patients receiving placebo plus methotrexate and/or other disease modifying anti-rheumatic drugs. Improvements were seen as early as four weeks after the first Simponi injection and continued to improve over time. A proportion of patients also achieved substantial improvements in arthritis symptoms, 50 percent improvement (ACR50) and 70 percent improvement (ACR70), with continued Simponi treatment.
A Phase 3 trial, the largest of its kind, evaluating Simponi in the treatment of psoriatic arthritis showed that Simponi 50 mg significantly improved signs and symptoms of active psoriatic arthritis. Similarly, a Phase 3 study evaluating Simponi in the treatment of ankylosing spondylitis showed that Simponi 50 mg significantly improved signs and symptoms of active ankylosing spondylitis. Patients with psoriatic arthritis and ankylosing spondylitis experienced rapid and sustained improvements with continuous Simponi treatment.
"With the approval of Simponi, we enhance our commitment to delivering effective and innovative treatments to the millions of patients living with chronic inflammatory diseases while expanding our immunology portfolio," said Kim Taylor, President, Centocor Ortho Biotech Inc. "Importantly, as patient safety remains our top priority, we have collaborated with the FDA to develop a Risk Evaluation and Mitigation Strategy to help ensure the risks of ant-TNF therapy are appropriately managed by doctors prescribing and patients receiving Simponi."
"The approval of new and effective treatment options is always good news for the arthritis community, as not all patients respond the same to currently available treatment options," said Dr. John Hardin, Chief Scientific Officer for the Arthritis Foundation. "Anti-TNF agents have become an important advancement in the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, and each approval offers physicians and patients yet another option within this important class of therapy."
About Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis affect more than three million Americans collectively. RA is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA. For more information visit the Arthritis Foundation.
Psoriatic arthritis is a chronic inflammatory disease that causes joint pain and swelling and can lead to joint destruction. Psoriatic arthritis is frequently associated with inflamed, scaly, red patches of skin psoriasis and nail psoriasis. According to the National Psoriasis Foundation, up to 30 percent of people with psoriasis also develop psoriatic arthritis. For additional information visit the National Psoriasis Foundation.
Ankylosing spondylitis is a painful and progressive form of spinal arthritis. In severe cases, the disease can result in fusing of the spinal vertebrae and cause structural damage to hips and other joints. An estimated 500,000 people in the U.S. are living with ankylosing spondylitis. For more information visit the Spondylitis Society of America.
About Simponi (golimumab)
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. The first once-monthly subcutaneous anti-TNF-alpha therapy, Simponi is approved for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, and is available either through the Simponi SmartJect autoinjector or a prefilled syringe. Simponi is also being studied as an intravenous infusion therapy for the treatment of rheumatoid arthritis. For more information about Simponi, visit www.simponi.com.
In March 2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Centocor Ortho Biotech Inc. developed and discovered Simponi and has exclusive marketing rights to the product in the United States. Following regulatory approval, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where Simponi will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where Simponi will be exclusively marketed by Janssen-Cilag; and China, where Simponi will be exclusively marketed by Xian-Janssen.
Important Safety Information
Simponi 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 Ohio and Mississippi River Valleys and the Southwest) 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 have diabetes. 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:
* fever, sweat, or chills
* muscle aches
* shortness of breath
* blood in phlegm
* weight loss
* warm, red, or painful skin or sores on your body
* diarrhea or stomach pain
* burning when you urinate or urinate more than normal
* feel very tired
Tell your doctor about all the medications you take or if you are scheduled to or recently received a vaccine.
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
* muscle aches
* dark urine
* clay-colored bowel movements
* stomach discomfort
* skin rash
If you take Simponi or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.
Heart failure can occur or get worse in people who use TNF blockers like Simponi. Your doctor will monitor you closely 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 can have nervous system problems such as multiple sclerosis. 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.
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. 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.
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, or chest pain. Common side effects of Simponi include: upper respiratory tract infection, nausea, abnormal liver tests, redness at site of injection, high blood pressure, bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores, numbness or tingling.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
The Full Prescribing Information and Medication Guide for Simponi will be available at www.simponi.com.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.CentocorOrthoBiotech.com. Centocor Ortho Biotech is a wholly-owned subsidiary of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 Centocor Ortho Biotech Inc. and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)