In December 2016 the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) reached a positive opinion regarding Idogen’s application for orphan drug status in Europe. Thus, COMP recommended that the European Commission grant Idogen an orphan drug designation. The European Commission has now formally approved Idogen’s application for orphan drug status in Europe for the treatment of patients with hemophilia A.
“That we have now received formal orphan drug status in Europe for our first product is extremely gratifying and important to us. This means that we now have free consultations with the European Medicines Agency and market exclusivity for the product ten years after approval, which is very valuable for our first product.” CEO Lars Hedbys commented.
For additional information about Idogen, please contact:
Lars Hedbys, CEO
Tel: +46 (0)46-275 63 30
This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 16th of January 2017.