Invasive Aspergillus infections recieves orphan drug as SCY-078 by SCYNEXIS

Release Date: 27-Nov-2016

Scynexis, a pharmaceutical company specialized in drug development, declared its triterpenoid broad-spectrum antifungal agent, SCY-078 as orphan drug as approved by Food and Drug Administration for the treatment of invasive Aspergillus infections. Previously, the company announced that SCY-078 has received orphan drug designation for the treatment of invasive Candida infections, including candidemia.


 The company was previously granted Qualified Infectious Disease Product (QIDP) designation for both the IV and oral formulations of SCY-078, which provides an additional five years of exclusivity. Together, these designations provide SCYNEXIS with a potential 12 years of market exclusivity in the U.S. upon FDA approval.


The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.


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