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What Is Orphan Drug Company Alexion Pharmaceuticals Presenting At The 2012 ASH Meeting ?

December 10, 2012

       Alexion Pharmaceuticals is presenting Abstracts for orphan drug Soliris (Eculizumab) at the 2012 Annual American Society of Hematology (ASH) Meeting, in Atlanta, Georgia, December 8 – 11, 2012 :

Treatment of Paroxysmal Nocturnal Hemoblobinuria (PNH) 

  1. Receives FDA Orphan Drug Designation (ODD) August 20, 2003 for PNH
  2. Receives FDA Approval for PNH orphan indication & exclusivity start date is March 16, 2007
  3. ASH Abstract # 3472 Eculizumab in Paroxysmal Nocturnal Hemoglobinuria (PNH): A Rep ort of All 153 Patients Treated in the UK
  4. ASH Abstract # 3197 A Rare Genetic Polymorphism in C5 Confers Poor Response to the Anti-C5 Monoclonal Antibody Eculizumab by Nine Japanese Patients with PNH
  5. ASH Abstract # 3480 Eculizumab Protects Against TE and Prolongs Survival in Patients with Paroxysmal Nocturnal Hemoglobinuria: An International PNH Registry Study
  6. ASH Abstract # 1260 Long-Term Safety of Sustained Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria.

  

Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)

  1. Receives FDA ODD for atypical Hemolytic Uremic Syndrome (aHUS) on April 29, 2009 
  2. Receives FDA Approval for aHUS orphan indication & exclusivity start date is September 23, 2011
  3. ASH Abstract # 985 Eculizumab (ECU) Safety and Efficacy in Atypical Hemolytic Uremic Syndrome (aHUS) Patients with Long Disease Duration and Chronic Kidney Disease (CKD): 2-Year Results
  4. ASH Abstract # 2084 Eculizumab (ECU) in Atypical Hemolytic Uremic Syndrome (aHUS) Patients with Progressing Thrombotic Microangiopathy (TMA): 2-Year Data
  5. ASH Abstract # 2085 Eculizumab Is an Effective Treatment for Atypical Hemolytic Uremic Syndrome in Patients with or without Identified Genetic Complement Mutations or Complement Factor H Auto-Antibodies.

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