FDA approves Extavia for multiple sclerosis

The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

Extavia is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI)(4).

The same medicinal product as Betaseron(R)*, Extavia offers patients and physicians a new branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for MS in the US for more than 16 years(1). Extavia will be marketed by the Pharmaceuticals Division of Novartis.

"Interferon is a mainstay of treatment in MS," said Doug Jeffery, MD, Associate Professor at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, USA. "With the approval of Extavia, patients have another option with a well-established safety and efficacy profile to help manage this disease."

MS is estimated to affect approximately 400,000 patients in the US, of whom more than 80% have relapsing-remitting MS(5). MS is one of the most common causes of neurological disability in young adults. It is a chronic autoimmune disease in which the body's immune system attacks the myelin sheath, or protective tissue surrounding the nerve fibers that carry electrical signals in the brain(6). The destruction of myelin causes problems with muscle control and strength, vision, balance, sensation and mental function(7).

"Novartis has been a leader in neuroscience for more than 50 years, having pioneered a number of breakthrough therapies which remain important treatments to this day," said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. "We are committed to providing new approaches to MS care, and the FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the US."

Extavia will be available to patients in the US this fall. Along with their prescription for Extavia, patients will be given access to a support program including a nurse helpline, one-on-one injection training and reimbursement support services. Extavia patients will have an autoinjector available to them from Novartis.

"MS is unpredictable and can be difficult to manage," said Aaron Miller, MD, Professor of Neurology at Mount Sinai School of Medicine in New York, USA. "Support programs are an essential element to help patients and physicians effectively manage this complicated disease."

MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (known as exacerbations or relapses), followed by complete or partial restoration of function(6).

Interferon beta-1b has been shown to reduce annualized relapse rates by 34%>

In the European Union Extavia is available in 12 countries and is approved for relapsing-remitting MS as well as early MS (defined as a single demyelinating event with an active inflammatory process) and a steadily worsening form of the disease known as secondary progressive MS with relapses.

Extavia should be used with caution in patients with depression. Injection site necrosis has been reported in 4% of patients in controlled trials. Typically, injection site necrosis occurs within the first four months of therapy. Necrosis may occur at a single injection site or multiple injection sites. Patient understanding and use of aseptic self-injection techniques and procedures should be periodically reevaluated, particularly if injection site necrosis has occurred. Anaphylaxis has been reported as a rare complication of interferon use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash, and urticaria.

The rate of flu-like symptom complex was approximately 57% in the four controlled clinical trials. The incidence decreased over time, with only 10% of patients reporting flu-like symptom complex at the end of the studies. Monitoring of complete blood and differential white blood cell counts, platelet counts and blood chemistries, including liver function tests, are recommended at regular intervals.

The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache and pain. Based on all the available evidence, the relationship between antibody formation and clinical safety and efficacy is not known. Female patients should be warned about the potential risk to pregnancy. The mechanism of action of interferon beta-1b in patients with multiple sclerosis is unknown. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Patients should be advised of the importance of rotating injection sites.

* Novartis gained the rights to seek approval for its own branded version of interferon beta-1b through agreements with Bayer Schering, the company that markets Betaseron.

Betaseron is marketed under the name of Betaferon(R) outside the US. Betaseron and Betaferon are registered trademarks of Bayer Schering Pharma AG.

http://www.novartis.com

References

1. FDA approves Betaseron(R) for use after the first event suggestive of multiple sclerosis [press release]. Wayne, NJ: Berlex: 23 October 2006.
2. National Multiple Sclerosis Society website: http://www.nationalmssociety.org/about-multiple-sclerosis/who-gets-ms/index.aspx. Accessed August 12, 2009.
3. Multiple Sclerosis International Federation website. http://www.msif.org/en/about_ms/what_is_ms.html. Accessed August 12, 2009.
4. Extavia Prescribing Information, August 14, 2009.
5. Habermann, T. and Amit K. Ghosh ed. Mayo Clinic Internal Medicine Concise Textbook. Florence, KY: Informa HealthCare, 2007.
6. National Multiple Sclerosis Society website. http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx. Accessed August 12, 2009.
7. Multiple Sclerosis International Federation website. http://www.msif.org/en/about_ms/symptoms.html. Accessed August 12, 2009.
8. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurology. 1993;43:655-661.
9. Betaseron (interferon beta-1b) Prescribing Information. Available online at http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf.
10. Kappos L, Freedman MS, Polman CH, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67:1242-1249.