Orphan drug development is not taking off

Abstract

How many orphan drugs?Since 2000, when the ad hoc legislation [3] came into force, up to 2007, out of 528 designated orphan indications related to 400 orphan medicinal products (OMPs) (http:// ec.europa.eu/enterprise/pharmaceuticals/register/index. htm), only 45 (44 drugs) were approved (8.5%) after a mean of 34.8 months (range 6-76 months); out of the 70 OMP marketing authorization applications, 44 were approved (62.9%),21 withdrawn (30%) and five rejected (7.1%).In the same period, out of 334 applications submitted for 'non-orphan' drugs, 236 (70.7%) were licensed (http:// www.emea.europa.eu/htms/human/epar/a.htm).

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