The fast track designation will provide an expedited review process rhC1INH. It also allows for more frequent interactions with the FDA, which could improve the efficiency of product development and decrease the typical review period.
There is no approved therapy available to hereditary angioedema (HAE) patients in the US for the treatment of acute attacks. Clinical studies of rhC1INH have shown that treatment with Pharming’s treatment candidate leads to rapid time to beginning of relief from the attack and reduces time to complete resolution.
The rhC1INH product has already been granted orphan drug status in this indication, which provides a seven-year period of market exclusivity in the US upon product approval.