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FDA Approves Prefilled Syringe for Avonex
AVONEX, the only once-a-week treatment for MS, is now approved in a convenient, prefilled syringe that makes it even easier to administer. Biogen expects the prefilled syringe to be available in August and replace the currently available form of AVONEX. As with the current form of AVONEX, the new formulation will be indicated to slow the progression of disability and reduce the frequency of relapses in relapsing forms of MS, including people who have experienced a first clinical episode and who have brain scans consistent with MS.
Burt Adelman, M.D., Biogen's Executive Vice President, Research and Development, said, "Biogen is pleased to provide patients with an AVONEX prefilled syringe. This formulation offers greater convenience for patients and, as with the existing formulation, has a neutralizing antibody rate of 5 percent."
All therapeutic proteins have the potential to cause an immune response in the human body, such as the production of specific antibodies. A subset of these antibodies, called neutralizing antibodies, can inhibit the biologic activity of the therapeutic protein. The clinical significance of neutralizing antibodies to AVONEX is unknown.
The most common side effects associated with AVONEX treatment are flu-like symptoms, myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX, which is administered by intramuscular injection, should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com.
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and approximately 1 million people worldwide. It is a disease of young adults, mostly women, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
AVONEX is the leading treatment for relapsing forms of multiple sclerosis worldwide, with more than 120,000 patients on therapy. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX is marketed internationally in more than 65 countries.
Source: Biogen, Inc.