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Achillion Pharmaceuticals kidney drug gets EMA backing for orphan status

Achillion Pharmaceuticals Inc. said the European Medicines Agency recommended the orphan drug status for the company's kidney treatment.

The European regulator's Committee for Orphan Medicinal Products issued a positive opinion, recommending ACH-4471 for the orphan status to treat C3 glomerulopathy.

The opinion will be submitted to the European Commission for a final verdict.

C3 glomerulopathy is a rare renal disease characterized by the presence of C3 protein fragments in the filtering units of the kidney. The disease affects about 4,000 patients in the U.S. and more than 4,000 individuals in Europe.

The drug designation may provide the New Haven, Conn.-based biopharmaceutical company with a 10-year period of market exclusivity if the drug is approved, as well as other financial and regulatory support.

The orphan drug designation is meant for treatments that affect no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available.