European Commission grants orphan drug designation for EVOCellic
Important milestone: EVOMEDIS has received Orphan Drug Designation from the European Medicines Agency (EMA) for its novel cell therapy drug for the treatment of severe burns.
Specifically, the Orphan Drug Designation (EU/3/22/2637) refers to the use of human allogeneic keratinocytes, for the treatment of partial deep dermal and full thickness burns. These skin cells, specially produced by a patented process, are the active component of the product EVOCellic, which is currently in preclinical development.
EVOMEDIS team leader and CEO, Dr. Martin Funk, who developed EVOCellic in collaboration with researchers and physicians from COREMED (Center for Regenerative Medicine and Precision Medicine of JOANNEUM RESEARCH), the Med Uni Graz, as well as LMU Munich, and TERM Würzburg, explains: "The Orphan Drug Designation is an important milestone for us and a strong signal to the outside world. It enables the EMA to grant us benefits for scientific/regulatory advice and regulatory fees even during the development of EVOCellic prior to approval. The development of such a product is only possible through close cooperation with national and international partners and at a place where such a cooperation is fostered like at the new ZWT ACCELERATOR at the Medical Science City Graz “
Prof. Lars Kamolz, Institute Director of COREMED and Director of the University Hospital for Surgery Graz, says: "Such projects and developments can only be implemented through integrated research and close cooperation between the different partners. We are pleased to be involved in this great project from the very beginning."
Orphan Drug Designation
The advantages of an Orphan Drug Designation are an accelerated approval process and market exclusivity in Europe for 10 years from the date of approval. The process thus supports the development of drugs for people suffering from rare, life-threatening diseases, that are often neglected by the biomedical research & development because of their rarity. The Orphan Drug Designation is granted to a medical substance by the EMA and FDA, if one of these particularly rare diseases (affects less than 1 in 2,000 citizen) can be treated with this drug. If an Orphan Drug Designation is to be granted, drug authorities check not only the actual rarity of the disease, but also whether the developer of the drug can provide initial indications of possible efficacy.