ImmuPharma hopes Lupus treatment will be fast-tracked by FDA
The London-based drug devloper ImmuPharma says a fast track approval for drug candidate IPP-201101 for the treatment of Lupus is on the cards following a recent meeting with the US Food & Drug Administration.
The London-based drug devloper ImmuPharma says a fast track approval for drug candidate IPP-201101 for the treatment of Lupus is on the cards following a recent meeting with the US Food & Drug Administration.
Lupus is a chronic, life-threatening autoimmune disease and the ImmuPharma meeting was held following the successful completion of the phase I trial of IPP-201101 and the initiation of the phase II trial, results of which are to be announced before the end of 2006.
The purpose of the meeting was to discuss technical and scientific information and the proposed clinical protocol design for IPP-201101. According to ImmuPharma, the FDA felt the existing data would support the proposed clinical development programme. It also provided useful advice on the construction of the remaining development activities.
IPP-201101 may be launched sooner than anticipated with a Phase 2/3 trial in 150 patients, if a correlation is shown between the current phase II biomarker end-points and clinical benefit.
If development is completed successfully, marketing approval could also be granted through the FDA "fast track mechanisms". This will require only a six month review period.