LEIDEN, Netherlands, Oct. 6 (UPI) -- Dutch biotech firm Pharming said Friday it has received U.S. orphan drug status for Rhucin, being tested for hereditary angioedema.
The drug is a recombinant human C1 inhibitor that the company is developing for treatment of attacks of hereditary angioedema.
The Food and Drug Administration grants orphan drug status to drugs that treat serious diseases that affect fewer than 200,000 people in the United States. If approved, the new treatment could get up to seven years' market exclusivity.
Under FDA's orphan drug program, Pharming said it has received a one-year grant of $344,861 to help develop the drug and could get additional funding.
"Pharming is committed to developing products for unmet medical needs. We appreciate the FDA's funding for Rhucin clinical development in the (United States) and the acknowledgement of Rhucin's promise as a treatment for HAE," said Pharming Chief Executive Officer Francis Pinto.
HAE is characterized by acute attacks of painful, sometimes fatal swelling of several soft tissues (edema), which can last as long as five days if left untreated.
