Vicore Pharma’s C21 drug for treating idiopathic pulmonary fibrosis (IPF) has officially became an orphan drug in the USA.
The Swedish drugmaker said on Friday that the american food and drugs safety watchdog, the Food and Drug Administratino(FDA), has approved its candidate’s orphan drug status. The drug will be approved for 7 years.
Vicore noted that orphan drug status means tax relief on costs for clinical testing performed in the USA, as well as support from the authorities.
In EU, C21 has been an orphan drug 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.