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Arthritis
Nitec's IND Application for Clinical Development With Lodotra Accepted by the FDA
October 8th, 2007
Nitec Pharma AG announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application submitted by Nitec for the initiation of clinical development for Lodotra. Following the positive results of a European Phase III trial (CAPRA-1; Circadian Administration of Prednisone in Rheumatoid Arthritis), Nitec submitted a dossier for marketing authorization in Europe. The FDA's acceptance of the IND will now allow Nitec to start clinical development of Lodotra in the USA. A second Phase III study (CAPRA-2), currently planned to be initiated in the second quarter of 2008 will include about 300 patients in the US...
Source: Biotech Business Week (2007-10-08)
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