Nitec's IND application for clinical development with Lodotra accepted by the FDA
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 and EU.
"The new Lodotra trial is highly relevant for rheumatoid arthritis patients. Lodotra reduces IL-6 levels and has great potential to improve the signs and symptoms of RA, such as morning stiffness," commented Professor Kenneth G. Saag of the University of Alabama at Birmingham, member of the scientific steering group in the planned Phase III trial.
Clinical trials of Lodotra have demonstrated that it is a treatment that can make a difference to the lives of patients with RA. Morning stiffness is a debilitating symptom of the disease with a significant negative impact on the lives of patients with RA and Lodotra now offer clinicians an effective potential treatment option.
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