Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

New Drug Approvals & Regulatory Updates, In Brief

Executive Summary

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

You may also be interested in...



Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs

Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme

Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs

Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme

Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs

Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme

Related Content

Topics

UsernamePublicRestriction

Register

PS051098

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel