Chelsea wins European orphan status

European drug regulators granted orphan drug status to Chelsea Therapeutics' remedy for hypotension, Droxidopa, and recommended the same for Progen's experimental liver drug, known as PI-88. Designed to promote drugs that treat deadly and rare diseases, the E.U.'s orphan drug program offers marketing exclusivity for up to 10 years.

Chelsea's Droxidopa drug treats a particular sort of low blood pressure stemming from Parkinson's or from multiple-system atrophy. Its European orphan status covers both disorders and lasts for 10 years. It already has orphan-drug status in the U.S.

PI-88 treats primary liver cancer; its orphan designation won't be official until the European Commission officially adopts it, probably by the end of the third quarter.

- see the release
- read the report from the Charlotte Business Journal

Related Article:
FDA grants Droxidopa orphan drug status. Report