Orenica (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
NEW YORK, August 07, 2007 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the supplemental biologics license application (sBLA) for Orencia (abatacept) for the treatment of pediatric patients with juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.
This sBLA is based on data from a double-blind, randomized trial that consisted of three periods: a four-month open-label lead-in treatment period in which all participants (6-17 years old) received Orencia and both clinical response and safety were assessed (Period A), a six-month randomized double- blind withdrawal phase in which responders received either Orencia or placebo and time to disease flare and safety were assessed (Period B), and an open- label phase in which all participants received Orencia in order to assess long-term efficacy and safety (Period C).
Orencia, which was discovered and developed by Bristol-Myers Squibb, is currently approved for use in adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more DMARDs such as MTX or TNF antagonists. Orencia is a selective modulator of a co- stimulatory signal required for full T-cell activation.
About Juvenile Idiopathic Arthritis
JIA -- also commonly known as juvenile rheumatoid arthritis (JRA) -- is a chronic, autoimmune disease, causing chronic pain, stiffness and swelling of the joints, which may ultimately lead to joint damage and deformities. The disease usually begins before the age of 16 and may affect up to 1 child in every 1,000 in the United States.
Important Safety Information about Orencia (abatacept)
Before receiving treatment with Orencia individuals should tell their doctor if they are taking a TNF blocker (e.g., Enbrel, Humira, Remicade) to treat rheumatoid arthritis (RA). Orencia should not be taken with these medications because of a higher chance of getting a serious infection. Individuals should also tell their doctor if they are taking Kineret to treat RA. Orencia should not be taken with Kineret. People taking Orencia should notify their doctor if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should let their doctor know if they have any kind of infection including an infection that is in only one place of the body (such as an open cut or sore) or an infection that is in the whole body (such as the flu). Having an infection could increase the risk for serious side effects from Orencia. It is also important for individuals to let their doctor know if they have an infection that won't go away or a history of infections that keep coming back.
People who have had tuberculosis (TB), a positive skin test for TB, recent close contact with someone who has had TB or develop any of the symptoms of TB (a dry cough that doesn't go away, weight loss, fever, night sweats) should call their doctor right away. Before starting treatment with Orencia, a doctor may examine the individual for TB or perform a skin test.
In addition, individuals should let their doctor know if they are scheduled to have surgery or any vaccination or have recently received a vaccination. People should inform their doctor if they have a history of chronic obstructive pulmonary (lung) disease (COPD). Taking Orencia may cause COPD symptoms to get worse.
People who have diabetes and use a blood glucose monitor to check their sugar levels should tell their doctor. The infusion of Orencia contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day the infusion is received. The doctor may recommend a different monitor.
Women who are pregnant, planning to become pregnant or are thinking about becoming pregnant should tell their doctor. It is not known if Orencia (abatacept) can harm an unborn baby. Women who are breast feeding should also inform their doctor. They will need to decide to either breast-feed or receive treatment with Orencia, but not both.
Important Information about Side Effects with Orencia
Like all medicines that affect your immune system, Orencia can cause serious side effects. The possible serious side effects include serious infections and allergic reactions. Also, rare cases of certain kinds of cancers have been reported.
People taking Orencia are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Individuals should call their doctor immediately if they feel sick or get any infection during treatment with Orencia.
Allergic reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion, and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing. There have been some serious allergic reactions reported after receiving an infusion of Orencia.
There have been rare cases of certain kinds of cancer. The role of Orencia in the development of cancer is not known.
The more common side effects with Orencia are headache, upper respiratory tract infection, sore throat, and nausea.
Dosing and Administration
Orencia is administered by a healthcare professional as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with Orencia and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion- related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
About Orencia (abatacept)
Orencia is currently indicated in the United States for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. Orencia may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. Orencia should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
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Posted: August 2007