Extavia (s/a Betaseron)
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Extavia Receives FDA Approval for Treatment of MS
August 18, 2009
On August 14, 2009, the United States Food and Drug Administration (FDA) approved Extavia® (interferon beta-1b) for the treatment of relapsing forms of multiple sclerosis (MS). Extavia is also approved for individuals who have had a clinically isolated syndrome (CIS), which refers to those who experience a single attack of one or more symptoms characteristic of MS, with a high risk of developing clinically definite MS (CDMS). Marketed by Novartis Pharmaceuticals Corporation, Extavia is the same medicinal product as the original interferon beta-1b for the treatment of MS, marketed under the brand name Betaseron®. No changes will occur in the marketing of Betaseron, which will continue to be available by prescription to MS patients. Extavia is scheduled to be available by prescription in the United States on October 1, 2009.
Beginning at that same time, Novartis will offer nursing support and education to individuals who may be prescribed Extavia. A telephone helpline as well as one-on-one training with injection procedures are among the services which will be provided. Extavia is given at the same dose and frequency as Betaseron: 250 micrograms administered via subcutaneous (under the skin) injection every other day. Prescriptions of Extavia will be packaged in groups of 15 vials per month (versus the current 14 vials per month). Patients may choose between traditional injections or using an autoinjector. Support services will include insurance advocacy and a reimbursement program for those who qualify.
Extavia will be joining six other disease-modifying therapies (DMTs) in the marketplace, all of which have been previously approved by the FDA for the treatment of MS. In addition to Betaseron, these include: Avonex® and Rebif® (interferon beta-1a); Copaxone® (glatiramer acetate); Novantrone® (mitoxantrone); and Tysabri® (natalizumab). Betaseron has been used in the United States for more than 16 years. For individuals with relapsing forms of MS, it has been shown to reduce relapse rates by 34 percent, and may slow disease progression. For individuals with CIS, almost 75 percent did not progress to CDMS following two years of treatment.
Flu-like symptoms and injection site reactions are among the commonly reported side effects with interferon beta-1b. These can often be minimized by gradual dose titration (starting with a low dose and increasing the dose slowly) and closely following injection instructions, along with the prophylactic use of analgesics during treatment initiation. Injection site necrosis (localized tissue death) has been reported in four percent of patients in controlled trials of interferon beta-1b, and usually occurs within the first four months of treatment. Allergic reactions are among the rare complications of interferon use.
Self-injection techniques should be re-evaluated periodically to ensure that proper procedures are being followed. As with other injectable treatments for MS, rotating the injection sites is important, although the specific rotation recommended for Extavia may differ slightly from that of Betaseron. Blood monitoring and liver function tests are also recommended at regular intervals. Additionally, female patients considering Extavia should be warned about the potential risks of interferon use with pregnancy. This drug should be used with caution in patients who also experience depression.
Novartis was given the rights to seek approval for its own branded version of interferon beta-1b through an agreement with Bayer Schering, the company which markets Betaseron. Outside of the United States, Extavia is presently available in 12 European countries for the treatment of MS. Betaseron is also available outside of the United States and is marketed as Betaferon®.
Novartis has information lines for anyone who has questions about Extavia. Members of the MS community may call (866) 925-2333 for more information. Healthcare professionals with product-specific questions may call 866-EXTAVIA, or (866) 398-2842 . Information is also available on Extavia’s website at www.extavia.com.
MSAA’s website offers a great deal of information through online publications and educational videos. Please select “Publications” to view or download any of MSAA’s written publications, or select “MSi” for on-demand videos. To speak with a Helpline consultant about MS, its treatments, and MSAA’s programs and services, or for additional support, individuals may call MSAA’s Helpline at (800) 532-7667.
Written by Susan Wells Courtney; Reviewed by Dr. Jack Burks.