Orphan drugs Japan

Official recognition of orphan drug status is accorded in the USA (pop 240 million) where the relevant disease affects fewer than 200,000 people in Japan (pop 121 million) for fewer than 50,000 people. 

Orphan Drug legislation has been passed in Australia and Japan, and is currently under consideration in a number of other Asian countries. In general, prevalence criteria have trended towards that used by the EU, and that in the USA remains relatively liberal. However, the use of a fixed number of 200 000 cases causes a progressive decrease in the prevalence criteria when the denominator is a growing US population (Fox 2002). 

Recombinant Erythropoietin"—In June 1989, Amgen received approval to market its version of recombinant erythropoietin (rEPO) for the treatment of anemia in patients with chronic renal failure. EPO is a protein usually produced by the kidneys and necessary for the production of red blood cells. Amgen had first produced the drug in 1983 and had received orphan status for it in 1986. In September 1988, Chugai Pharmaceuticals of Japan, in a joint venture with Upjohn Pharmaceuticals, filed a PLA with the FDA to market its own version of rEPO in competition with Amgen. 

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