 
|
... July 10, 2003 ...
Aventis Behring:
Receives FDA Approval for Zemaira
for Alpha-1-Proteinase Inhibitor Deficiency and Emphysema
Zemaira(TM) Is a New, Safe, And Effective Chronic Augmentation and Maintenance Therapy that Can Offer Benefits to Patients
Aventis Behring L.L.C. announced today that Zemaira(TM) (alpha(1)-proteinase inhibitor (human)) (A(1)-PI) has received approval from the U.S. Food and Drug Administration for use as chronic augmentation and maintenance therapy in individuals with alpha(1)-proteinase inhibitor deficiency (Alpha-1), a life-threatening genetic disorder in some individuals, who demonstrate clinical evidence of emphysema. Left untreated, this form of emphysema can be fatal.
"Zemaira(TM) establishes a new standard for intravenous therapy for Alpha-1 patients. Zemaira(TM) was purposely developed to be a high purity product that requires half the infusion volume and approximately half the infusion time of other currently available therapies. In clinical trials, Zemaira(TM) maintained alpha(1)-proteinase inhibitor levels above the historical target threshold," said Dr. Ruedi Wager, chief executive officer, Aventis Behring. "Additionally, Zemaira(TM) can also be stored and transported at room temperature, allowing people with A(1)-PI flexibility in their lifestyle."
"Aventis Behring has invested approximately $170 million and many years in the development of therapies for the Alpha-1 Community. We are pleased that Zemaira(TM) will provide a new choice for those people who need it," continued Dr. Wager.
Zemaira(TM) will soon be available to the Alpha-1 Community. Historically, people with Alpha-1 have been concerned with the critical short supply of the therapy. Zemaira(TM) underlines Aventis Behring's commitment to the underserved Alpha-1 Community. By developing a high quality product using new state-of-the-art purification technology, Aventis Behring will provide desperately needed product so people with Alpha-1 can focus more on their lives and less on when their therapy will be available."
"With the protein content of each dose being at least 90% A(1)-PI protein, we believe that Zemaira(TM) establishes a new standard in purity that results in less non-therapeutic proteins being introduced to people with Alpha-1," said Dr. Robert Sandhaus, clinical director and executive vice president, Alpha-1 Foundation. "Additionally, the Alpha-1 Community is grateful that more treatment is becoming available for this often unrecognized or misdiagnosed disease."
Because Alpha-1 is a serious or life-threatening condition, Zemaira(TM) received Fast Track designation from the FDA in November 2000. The license application, submitted in January 2003, received a priority review by the FDA. Under the FDA Modernization Act of 1997, the FDA facilitates and expedites the development and review of the application for the approval of a new drug if it is intended for the treatment of a serious or life-threatening condition and has the potential to address an unmet medical need.
Aventis Behring has also developed a new program for those who will be treated with Zemaira(TM). The Zemaira(TM) Assurance Program is designed to ensure that qualified people who rely on this product can continue to receive Zemaira(TM) even if they experience a lapse in third-party, private health insurance.
Patients and healthcare professionals should visit www.Zemaira.com or call 1-866-Zemaira (1-866-936-2472) for more information about Zemaira(TM) and Aventis Behring's unique programs.
Telephone: 540-948-6777 or 1-866-FOR-A1AA (1-866-367-2122) Fax # 540-948-6763
Copyright © 2003 Alpha-1 Advocacy Alliance, All Rights Reserved
Home | Disclaimer | Privacy Policy