A wholly-owned subsidiary of Neurochem Inc. (Nasdaq: NRMX; TSE: NRM), Neurochem (International) Limited (Neurochem) has submitted a complete response to the USFDA’s August 2006 approvable letter for KIACTA™.
Neurochem’s KIACTA™ (eprodisate; formerly FIBRILLEX™) is the company’s investigational product candidate seeking marketing approval of for the treatment of Amyloid A (AA) amyloidosis.
AA amyloidosis is a deadly disease which often destroys kidney function that as of today still has no specific treatment.
The complete response includes the data on safety and efficacy from a follow-up of all 183 patients who were enrolled in the Phase II/III clinical trial.
Following the suggestion of the FDA in its approvable letter, Neurochem successfully retrieved the most recent health information (i.e. dialysis/end stage renal disease (ESRD) or death from all causes, regardless of when the clinical event occurred) for all 183 study subjects, including patients currently enrolled in the open-label extension study and all patients who discontinued their participation in the study.
The median time of follow-up was approximately 36 months.
Find more details of the clinical data from Neurochem’s press release.
Learn more about AA amyloidosis from Neurochem’s brochure (a pdf file).
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