Vanessa Research (VR) has been granted positive orphan drug opinion by the European Medicines Agency (EMA) for their drug Shylicine™ (patent pending).
This represents a huge milestone in developing treatment for microvillus inclusion disease (MVID), an extremely rare disease, to which the team at Vanessa Research has been dedicated.
“This designation means the Agency supports our drug by providing assistance in such critical areas as clinical trials and quality development, making the approval process faster and easier, and reducing the regulatory burden for Shylicine™ as it moves closer to being approved for use in patients,” said Dr. Dmitry Kravtsov, vice president for Research and Development.
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Microvillus inclusion disease is a rare pediatric disorder that causes chronic diarrhea. The goal of this oral anti-diarrheal treatment is to restore intestinal function so patients can eat and drink normally.
“Our team worked very hard toward getting an orphan drug status for Shylicine™. Having this positive opinion from EMA is the best gratification we could hope for,” said Dr. Kravtsov.
VR, a University of Connecticut Technology Incubation Program participant, has global offices in Hungary, Spain and Germany in addition to its Hamden, Conn. corporate campus.