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FDA Grants Fast Track Review For Emphysema Treatment Candidate KING OF PRUSSIA, PA -- December 20, 2000 -- Aventis Behring L.L.C. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for the development of a potential intravenous treatment for alpha-1 antitrypsin deficiency (A1AD) related emphysema. The investigational drug is Alpha1 Proteinase Inhibitor IV (Human), which is currently being studied in Phase III clinical trials. Alpha-1 Antitrypsin Deficiency affects approximately 100,000 Americans, according to the Alpha One Foundation, a not-for-profit organization dedicated to increasing the awareness and early diagnosis of this life-threatening genetic disorder. A1AD may affect both the structure and the function of the lungs and can lead to chronic emphysema and premature death if left untreated. "Alpha-1 Antitrypsin Deficiency is a serious hereditary condition and as a result, the FDA has determined that this treatment warrants an accelerated clinical development and review period," said Dr. Ruedi Waeger, CEO of Aventis Behring, L.L.C. "We are pleased with the Fast Track designation, and believe that the FDA supports our research efforts in patients associated with A1AD related emphysema." "We are pleased that the FDA has recognized the critical situation shared by the Alpha -1 community. Alpha-1 Antitrypsin Deficiency is one of the most under-recognized and underdiagnosed hereditary disorders in the United States," said John W. Walsh, President and CEO of the Alpha One Foundation. "We are extremely impressed with Aventis Behring's commitment to help alleviate the unmet medical needs of Alpha-1 patients." Designation as a Fast Track drug, under the FDA Modernization Act of 1997, means that the FDA will facilitate and expedite 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 demonstrates the potential to address an unmet medical need. Related Link: Aventis Behring L.L.C.. E-mail this page to a friend or colleague! To print, use this version