FDA Grants Priority Review of Talecris Biotherapeutics's Gamunex as a Treatment for Neurological Disorder CIDP
RESEARCH TRIANGLE PARK, N.C. -- Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted a Priority Review of Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
The Priority Review designation is intended to expedite the review process for therapies that may provide a significant improvement in the treatment of serious or life-threatening diseases. Based on this Priority Review status, the FDA reviews the application with the goal of taking action within six months of the sponsor's submission of supplemental Biologics Application (sBLA).
â€œWe are encouraged that the FDA has determined the application meets its criteria for such review, and look forward to working with the agency as it continues its review process,â€ said Stephen Petteway, Senior Vice President, Research and Development for Talecris Biotherapeutics.
CIDP is a progressive or relapsing disease affecting two to seven individuals per 100,000 worldwide. Its course is variable. The most common symptom patients experience is progressive weakness in the arms and legs resulting in significant disability.
Chronic inflammatory demyelinating polyradiculoneuropathy (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 â€” which usually develop slowly over weeks and progress over several months â€” 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 young 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 idiopathic thrombocytopenic purpura (ITP).
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.
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.
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 4,000 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.