The company’s IDO 8 has been granted orphan drug designation in the USA.
Idogen has previously been granted orphan drug designation in the EU for IDO 8. This is now being complemented with the grant in the United States, a significant progress for the company, it reports.
Seven years of market exclusivity
IDO 8 is Idogen’s most advanced project, aimed at developing a tolerogenic cell therapy for patients with severe haemophilia who have developed inhibitory antibodies against their regular treatment. Idogen´s cell therapy has potential to restore the original efficacy of factor VIII treatment.
“The orphan drug designation in the United States means that we now receive support from the FDA during the development work and seven years of market exclusivity after launch. This facilitates further development and potential commercialization of our cell therapy, which targets a well-defined group of hemophilia patients in great need of improved treatment,” Idogen´s CEO Lars Hedbys comments.