The European Medicines Agency (EMEA) has been formally notified by Canadian drugmaker Neurochem of its decision to withdraw the application for a centralized marketing authorization of its drug Kiacta (eprodisate disodium) capsules. This was under development for the treatment of amyloid A amyloidosis, a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Could not conduct further trials in time
The application for marketing authorization for Kiacta was submitted to the EMEA on September 4, 2006. The Committee for Medicinal Products for Human Use (CHMP) had given a negative opinion recommending the refusal of marketing authorization late last year (Marketletter December 24, 2007). The company had requested a re-examination of the negative opinion, but this had not finished when it decided to withdraw its application.
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