FDA Approves Gamunex for Chronic Inflammatory Demyelinating Polyneuropathy
FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sept. 15, 2008 - Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills.
Through its approval, Gamunex is the only therapy of any kind with an approved indication for the treatment of CIDP. Gamunex now has the broadest set of FDA-approved indications of any liquid Immune Globulin Intravenous (IGIV) therapy. Gamunex also becomes the first and only IVIG therapy approved to treat any neurological disorder in the United States. The FDA's ruling provides Orphan Drug Designation for Gamunex to treat CIDP. The FDA grants Orphan Drug Designation to encourage biotechnology and pharmaceutical companies to develop products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 people in the United States. This designation grants Talecris marketing exclusivity for the treatment of CIDP with Gamunex for seven years.
"For the first time ever, U.S. patients with CIDP will finally have an FDA-approved medication to help limit peripheral nerve damage in this disorder leading to improved neurological function and quality of life," said Estelle Benson, executive and founding director of the GBS/CIDP Foundation International. Established in 1980, the Foundation is the only voluntary, nonprofit organization that provides support to Guillain-Barre Syndrome (GBS)/CIDP and their families, awards grants to researchers and offers education to the public and professional communities. "I speak on behalf of the 26,000 members of the GBS/CIDP Foundation, who are excited to learn that Talecris has established that Gamunex is a successful treatment for patients with CIDP. What good news!"
Talecris is developing programs to educate neurologists on this indication and the clinical trial which proved the efficacy supporting the new indication.
"We are proud to be the first company to prove the efficacy of an IGIV product for CIDP," said Lawrence Stern, president and chief executive officer for Talecris Biotherapeutics. "For people with this neurological disorder, Gamunex provides a safe and effective method of treatment. To help provide patients access to this important therapy, we are working to substantially increase supplies of Gamunex in 2009."
To secure the indication, Talecris conducted the first and only large-scale clinical trial for the treatment of CIDP. This study validates the long-term safety and efficacy of Gamunex as the first line and maintenance treatment for CIDP. This landmark study was published in the February 2008 issue of The Lancet Neurology.
"This was a remarkable study that provided the most compelling evidence of the short and long-term efficacy of IGIV in CIDP," said Dr. Marinos Dalakas, M.D., director of the Neuromuscular Division at Thomas Jefferson University in Philadelphia, Pa. "It is great news for the thousands of CIDP patients in this country who now have a chance to receive IGIV as an approved indication on a long-term basis and lessen the disabling effects of this disease."
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a neurological disorder often characterized by progressive weakness and impaired sensory function in the legs and arms. This disorder is caused by damage to the myelin sheath (the fatty covering that wraps around and protects nerve fibers) of the peripheral nerves. Signs and symptoms -- which usually develop slowly over weeks and progress over several months -- may include weakness of the arms, legs and face; tingling and numbness in the arms and legs (often beginning in the fingers and toes); as well as muscle aches and fatigue. CIDP, affecting two to seven individuals per 100,000 worldwide, can occur at any age and in both genders, although it is more common in elderly adults and in men.
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI), and as immunomodulatory therapy for both idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. 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.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information. The package insert is currently being revised to incorporate the CIDP indication and supporting information.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,500 talented people worldwide.
To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
Talecris Biotherapeutics, Inc.
Wendy Wilson, 919-316-2430
Posted: September 2008