The not approvable letter was previously issued by the FDA to Jerini in 2008 for Firazyr as the treatment for acute attacks of hereditary angioedema (HAE).
Firazyr is a synthetic decapeptide (a peptide containing ten amino acids).
Shire has organized an additional Phase III clinical study (FAST-3), as advised by the FDA in its letter earlier, and also reported positive efficacy and safety results in December 2010.
The company’s complete response is based primarily on recent results from the FAST-3 study and the ongoing self-administration study, as well as the previously published FAST-1 and FAST-2 studies.
Shire HGT president Sylvie Gregoire said they look forward to continued collaboration with the FDA to bring forward an important new therapeutic option for HAE patients.