Endo International PLC said Novitium Pharma LLC received the U.S. Food and Drug Administration's approval for the first generic version of Swedish Orphan Biovitrum AB (publ)'s medicine Orfadin to treat a rare inherited metabolic disorder.
East Windsor, N.J.-based Novitium is a partner of Endo subsidiary Endo Ventures Ltd.
Orfadin is used to treat adult and pediatric patients with hereditary tyrosinemia type 1, or HT-1, in combination with dietary restriction of the amino acids tyrosine and phenylalanine.
HT-1 is a rare and serious inherited metabolic disease caused by the inability to metabolize the amino acid tyrosine, which leads to elevated levels of the acid. The condition — which can lead to liver, kidney and peripheral nerve damage — affects at least 1 in 100,000 patients worldwide, with about 150 patients in the U.S., the company said in a Sept. 4 press release.
Endo unit Par Pharmaceutical Inc. plans to distribute the generic drug through specialty pharmacies from September.
Global sales of Orfadin for the past four quarters were about $85 million.
