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Genzyme Will Act Fast To Design Post-Market Myozyme Study By Review Date

Executive Summary

The on-time approval of a larger production scale of Genzyme's Pompe Disease biologic Myozyme could hinge on development of a post-market study protocol prior to the Nov. 29 PDUFA date

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New Drug Approvals & Regulatory Updates, In Brief

Inhaled insulin could be back: After a last-minute delay in the submission of MannKind's NDA for Afresa, FDA has accepted the March 16 filing and given the product a standard review - which puts the user fee deadline in mid-January. The ultra rapid-acting insulin (MannKind is no longer using the term inhaled insulin) is proposed for treatment of adults with type 1 or type 2 diabetes mellitus. Despite being the last oral inhaler insulin still standing in development, MannKind argues the feature that distinguishes Afresa from other insulin products is not the route of administration, but its pharmacokinetic profile (1"The Pink Sheet" DAILY, March 16, 2009). The lung's large surface area provides access to the circulatory system, where pH-sensitive Afresa particles dissolve upon contact with the lung, releasing insulin monomers that enter the bloodstream. The NDA submitted March 16 is based on a 49-study clinical program that included over 5,300 patients. More than 2,450 subjects with type 1 or type 2 diabetes were randomly assigned to treatment in the pooled controlled Phase II/III clinical studies. The clinical pharmacology program included more than 450 subjects exposed to Afresa in single-dose studies, which meets the current guidance from FDA regarding diabetes therapy development

New Drug Approvals & Regulatory Updates, In Brief

Inhaled insulin could be back: After a last-minute delay in the submission of MannKind's NDA for Afresa, FDA has accepted the March 16 filing and given the product a standard review - which puts the user fee deadline in mid-January. The ultra rapid-acting insulin (MannKind is no longer using the term inhaled insulin) is proposed for treatment of adults with type 1 or type 2 diabetes mellitus. Despite being the last oral inhaler insulin still standing in development, MannKind argues the feature that distinguishes Afresa from other insulin products is not the route of administration, but its pharmacokinetic profile (1"The Pink Sheet" DAILY, March 16, 2009). The lung's large surface area provides access to the circulatory system, where pH-sensitive Afresa particles dissolve upon contact with the lung, releasing insulin monomers that enter the bloodstream. The NDA submitted March 16 is based on a 49-study clinical program that included over 5,300 patients. More than 2,450 subjects with type 1 or type 2 diabetes were randomly assigned to treatment in the pooled controlled Phase II/III clinical studies. The clinical pharmacology program included more than 450 subjects exposed to Afresa in single-dose studies, which meets the current guidance from FDA regarding diabetes therapy development

Earnings Healthy, Genzyme’s Bigger-Batch Myozome Plant On Track For Approval

2,000-liter version of Pompe therapy, rebranded as Lumizyme, due for action later this month.

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