FDA has granted orphan drug designation for Vicore Pharma’s drug candidates C21 for the treatment of IPF. C21 is thereby approved as an orphan drug in the USA. The approval brings C21 exclusivity on the US market from when the drug will be approved and for 7 years thereafter. Other benefits related to orphan drug designation include tax relief on the costs for clinical trials executed in the USA and support from the authorities with scientific advice relating to the design of forthcoming clinical trials.
C21 holds the corresponding orphan drug status in the EU since august 2016.
Orphan drug designation provides us safety and support by the authorities during the continued clinical development process for C21 as a new therapy for IPF, an encouraging circumstance as we go forward. We can also note that the interest for our technology among the pharmaceutical companies is increasing the regulatory achievement says Per Jansson, CEO Vicore Pharma.