Pharmaprojects R&D Pipeline News Feed
European and US filings for eprodisate withdrawn
25 Mar 2008
The Canadian biopharmaceutical company Neurochem has withdrawn marketing applications in the EU, Switzerland and the US for eprodisate (Kiacta). Eprodisate is an orally-available amyloid deposition inhibitor, under development for the treatment of amyloid A amyloidosis.
Despite having previously granted orphan and fast-track status, the FDA and the EMEA both requested an additional confirmatory Phase III trial before approval. A 183-patient Phase II/III trial was conducted and suggested that eprodisate was effective, but failed to meet the primary endpoint of the number of patients whose kidney function got significantly worse or who died over two years (24% on eprodisate vs 40% on placebo). An extension study showed risk of any 'worse' event was reduced in continuously-treated patients to 41% compared with delayed treatment, and the product also reduced the risk of worsening of kidney function. The delayed treatment group also showed 55.1% slower rate of decline in renal function.
Amyloid A amyloidosis is a progressive and fatal condition that affects around 3,000 people in the US. It occurs in patients with long-lasting inflammation, most commonly rheumatoid arthritis, chronic infections and inherited diseases such as familial Mediterranean fever. The disorder mainly affects the kidney, and most patients die from end-stage renal disease. There are no approved treatments for the condition, and around half of patients die within five years of diagnosis.
