Hereditary Angioedema

This paper will build on your knowledge of Hereditary Angioedema
Firazyr (icatibant) was approved in 2011 for the treatment of acute attacks of HAE
For your next paper prepare a case-study of the drug you chose for the first paper.
Conduct this exercise as if you are a regulatory professional seeking information to aid you in the preparation of a regulatory development plan for a new sub-lingual drug for the treatment of HAE
Your case study should be in two parts and include
Part 1 – Drug description
? Description of the drug – chemistry, mechanism of action, etc.
? Specific indication for use – patient population
? Discussion of the clinical development plan – number and types of studies conducted, primary and secondary endpoints used in phases II and III, results
? Discussion of the nonclinical development plan – keep this very high level
? Safety issues and how they were mitigated
Part 2 – Development plan for our fictional new drug
? Non-clincal studies (very high level)
? What type of clinical trials and how many, endpoints, etc
? Fast track? Would your new drug be eligible?
? Orphan? Would your new drug be eligible?
? Other key development information
There are multiple sources of information for these drugs.
Please keep this to 10 pages