iCoat Medical’s drug candidate, iCM012, received orphan drug designation from the EMA in April 2022 and from the FDA in October 2022
In order to support development of treatments for patients that suffer from rare diseases and where there is an unmet medical need, authorities all over the world have introduced the classification Orphan Drugs.
The American legislation (American Orphan Drug Act) 1983 created several incentives for health companies to develop medicines in order to prevent, diagnose or treat rare diseases, that affect less than 200,000 individuals in the US. These incentives include:
- Seven years’ market exclusivity from the date of market approval.
- Support in designing clinical studies
- Tax deductions on costs related to clinical studies.
- No fees to FDA
- Possibility to receive grants from FDA
EUs corresponding legislation was adopted by the EU Parliament on December 16, 1999 in order to determine procedures for Orphan Drug status and stimulate the development of Orphan Drugs. A disease the needs Orphan Drugs is defined as a serious or life threatening disease or condition that affects a maximum of 5 out of 10,000 European citizens and that lacks a sufficiently good treatment. In 2022, EMA (European Medicines Agency) approved iCoat Medical’s application for Orphan Drug status for iCM012 in connection to kidney transplants. EUs Orphan Drug status provides benefits such as ten years’ market exclusivity for iCM012 from the date of market approval, support during clinical studies and reduced regulatory fees.