FDA extends Orphan Drug Designation to Enzychem Lifesciences’s EC-18 for treatment of ARS

Enzychem Lifesciences Corp asserted that the US Food and Drug Administration has granted Orphan Drug Designation to EC-18 for treating Acute Radiation Syndrome.

US FDA Orphan Drug Designation program advocates companies that are developing therapies thereby incentivising them for developing therapies meant for treating rare diseases afflicting less than 200,000 US people. Acute radiation syndrome includes neutropenia, nervous system damage, and pneumonia with high fatality rate. US government encourages development of new drugs for ARS in response to increasing threat of bioterrorism. FDA approval is followed by certain innumerable benefits like seven-year term of market exclusivity, tax credits for clinical research costs.

Enzychem Lifesciences Chief Executive Officer Ki Young Sohn said “With award of the Orphan Drug Designation for EC-18, Enzychem aims to develop medicines that enhance patients’ health and, especially, to address unmet clinical needs from the current market.”