Mucopolysaccharidosis Type

• FDA approval · 2011-07-13
  FDA Approved: ALDURAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for Aldurazyme (laronidase) by Genzyme Corporation, updating labeling through a supplemental approva…

• FDA label_change · 2010-05-14
  FDA Approved: ALDURAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for ALDURAZYME (laronidase) submitted by Genzyme Corporation.

• FDA approval · 2009-08-25
  FDA Approved: ALDURAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for Aldurazyme (laronidase) submitted by Genzyme Corporation, indicating an FDA action related to an…

• CLINICAL_TRIALS trial_result · 2009-08-19
  Clinical Trial Update: Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I [Phase 3]

  Phase 3 study of Aldurazyme in patients with mucopolysaccharidosis type I (Hurler and Hurler-Scheie) has completed, with results posted in 2…

• CLINICAL_TRIALS trial_result · 2009-06-16
  Clinical Trial Update: A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old [Phase 2]

  Phase 2 study evaluating the safety and pharmacokinetics of Aldurazyme (laronidase) in patients under 5 years old with mucopolysaccharidosis…

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• CLINICAL_TRIALS trial_result · 2009-06-16
  Clinical Trial Update: Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients [Phase 3]

  This Phase 3 extension study evaluated the safety and efficacy of Aldurazyme (laronidase) in patients with Mucopolysaccharidosis I and has c…

• CLINICAL_TRIALS trial_result · 2009-06-16
  Clinical Trial Update: A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease [Phase 4]

  Phase 4 dose-optimization study of Aldurazyme (Laronidase) in patients with Mucopolysaccharidosis I completed with results posted in 2009.

• FDA approval · 2009-05-20
  FDA Approved: ALDURAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for ALDURAZYME (Laronidase) from Genzyme Corporation, updating aspects of the approved product.

• FDA label_change · 2008-04-14
  FDA Approved: ALDURAZYME — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for ALDURAZYME (laronidase) from Genzyme to update the product labeling for its use in mucopolys…