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news.Neurochem has reported that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has issued a negative opinion recommending refusal of the marketing authorization application for eprodisate, for the treatment of Amyloid A amyloidosis.
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The Committee for Medicinal Products for Human Use (CMPH) concluded that another study would be needed to demonstrate eprodisate’s (Kiacta) effectiveness. The company is currently reviewing all of its options in view of this opinion, including the option of requesting a re-examination of the opinion by CHMP. As provided by the European regulations, the company may request that the CHMP consult a Scientific Advisory Group (SAG) in connection with the re-examination.
Francesco Bellini, chairman, president and CEO of Neurochem, said: “In view of the clinical benefit Kiacta has shown on the kidney function of patients, we are considering making a request for re-examination of the opinion which could lead to a decision as early as the second quarter of 2008.”