San Diego-based Lumena Pharmaceuticals Inc. announced its drug LUM001 has received a positive opinion for orphan drug designation from a European regulatory committee.
This news comes on the heels of the drug receiving orphan designation in September from the U.S. Food and Drug Administration. Both governing agencies approved orphan status for four rare liver diseases.
The company said in a release that LUM001 has been studied in more than 1,400 patients in 12 clinical studies.
The positive opinion from the European regulatory committee has now been forwarded to the European Union commission for final approval, Lumena said. Orphan medicinal products receive 10 years of market exclusivity in the EU after receiving marketing authorization.
— SDBJ Staff Report