Rebranded Vanessa Biotech earns FDA “orphan” status for pediatric rare-disease drug
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Vanessa Research’s flagship experimental drug, Shylicine.
Federal health regulators have granted “orphan drug” status to a Hamden biotech’s experimental treatment for a rare intestinal disease that can be deadly to infants.
Vanessa Biotech (formerly Vanessa Research) said its flagship drug Shylicine would be the first to treat microvillus inclusion disease (MVID), which is similar to cholera but sometimes more severe.
The inherited disorder causes chronic diarrhea in infants.
The Food and Drug Administration designation makes Vanessa eligible for tax credits, reduced regulatory fees and seven years of market exclusivity if the drug is approved.
It aims to encourage companies to develop drugs for rare diseases affecting fewer than 200,000 people in the U.S.
Shylicine earned a similar designation last October from health regulators in Europe, where the drug is undergoing Phase 2 testing in humans.
“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,” Adel Egri, Vanessa’s manager of regulatory affairs, said in a statement.
The company rebranded as Vanessa Biotech earlier this month, saying its new name is a better reflection of its evolution as a global business with multiple offerings in the biotechnology space.
Besides its U.S. headquarters on Sherman Ave. in Hamden, the company has a satellite office at the UConn Technology Incubation Program in Farmington as well as global offices in Hungary and Spain.
Contact Natalie Missakian at news@newhavenbiz.com
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