JERINI INITIATES PIVOTAL REGISTRATION STUDY FOR ICATIBANT IN HEREDITARY ANGIOEDEMA
Jerini announced today the start of its US and Canadian pivotal registration study with Icatibant for the treatment of hereditary angioedema (HAE). An Investigational New Drug Application (IND) and clinical trials Application (CTA) have been filed with the FDA and Health Canada, respectively. Both, IND and CTA are active. The final protocol for a European multi-center pivotal registration study will be submitted to the competent authorities and ethics committees in September. In both multi-center studies, named FAST 1 (For Angioedema Subcutaneous Treatment) in US/Canada and FAST 2 in Europe, patients will be treated with a subcutaneous formulation of Icatibant.
"We are extremely pleased with Icatibant´s rapid clinical development and are especially hopeful that HAE patients will be able to benefit from this novel medicine in the very near future," stated Jens Schneider-Mergener, CEO of Jerini.
Jerini has been granted orphan drug status by the FDA and EMEA (European Agency for the Evaluation of Medicinal Products) for Icatibant in the treatment of hereditary angioedema in the case of FDA approval. Orphan drug designation secures Icatibant seven years of market exclusivity in the United States and ten years in Europe. Moreover, Jerini received a fast track designation from the FDA for Icatibant in this indication. This designation helps to facilitate the development of the drug and expedite the review process.
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