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Hamden biotech’s drug earns ‘orphan’ status in Europe

Health regulators in Europe have granted “orphan” status to a rare disease drug being developed by Hamden-based Vanessa Research.

The designation by the European Medicines Agency provides incentives for companies developing drugs that are intended for small numbers of patients, to offset the limited commercial opportunities.

Companies developing orphan drugs are eligible for fee reductions, scientific advice and market exclusivity once the drug is approved, according to the EMA website.

Vanessa’s drug, Shylicine, targets the extremely rare microvillus inclusion disease (MVID), which causes chronic and potentially fatal diarrhea in infants, similar to cholera.

Vanessa’s oral anti-diarrheal treatment aims to restore intestinal function so patients can eat and drink normally. 

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Dr. Dmitry Kravtsov, Vanessa’s vice president for research and development, said the orphan designation would qualify the company for assistance in critical areas such as clinical trials and quality development “making the approval process faster and easier.”

Vanessa is a participant in UConn’s Technology Incubation Program (TIP) and has offices in Hungary, Spain and Germany in addition to its Hamden headquarters.

Contact Natalie Missakian at news@newhavenbiz.com

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