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