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Support For Serdolect In Specific Patients, But Panel Can’t Define Population

Executive Summary

The only way Lundbeck's schizophrenia drug might make it to market is if the sponsor and FDA can find a population where the benefits merit the cardiovascular risk and come up with a way to manage that risk. But it's more complicated than meets the eye, and not necessarily something a Risk Evaluation and Mitigation Strategy can handle

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FDA Complete Response Slows Down, But Won't Stop, Lundbeck's Serdolect

Agency comes to same conclusion as advisory committee: the risky schizophrenia drug could get approved if an appropriate patient group is identified.

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

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