FDA Grants Orphan Drug Designation for Shylicine™

Vanessa Biotech, the Hamden, Conn.-based global biomedical company dedicated to making an impact on healthcare markets, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the drug Shylicine™ (patent pending). Shylicine™ is the only treatment of its kind developed for microvillus inclusion disorder (MVID), a very rare and often lethal genetic pediatric disorder. In October 2020, Shylicine™ received orphan drug designation from the European Medical Agency (EMA). The drug is currently in Phase II clinical trials. “Receiving orphan drug designation from the FDA is significant because it clears a major milestone to getting the life-saving drug into the hands of MVID patients in the United States,” said Adel Egri, Regulatory Affairs Manager at Vanessa Biotech. FDA approval is also noteworthy given the treatment Shylicine™ can provide. “We are very happy and proud of receiving an orphan drug status for Shylicine. FDA continuously supports development of novel therapies for rare diseases, and now our drug has been added to the list of treatments supported by the Agency,” said Dr. Dmitry Kravtsov, Vice President of Research and Development.