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.
About Vanessa Biotech
Vanessa Biotech is a biomedical company founded on the desire to “give hope where none existed” by making an impact on healthcare markets often overlooked. Its continually expanding pipeline of innovative pharmaceuticals, medical devices, and consumer and public health products reflects the company’s inventive nature and commitment to delivering solutions that increase access to quality care. The company’s flagship product, Shylicine™, is the first-ever drug developed to treat the rare and lethal microvillus inclusion disease. Vanessa Biotech, a University of Connecticut Technology Incubation Program participant, has global offices in Hungary, Spain and Germany in addition to its Hamden, Conn. corporate campus.
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