CHMP requests more Kiacta data for approval

Canadian drugmaker Neurochem says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended refusal of the Marketing Authorization Application for Kiacta (eprodisate) for amyloid A amyloidosis and concluding that another study would be needed to demonstrate the agent's effectiveness.

The company is currently reviewing all of its options in view of this opinion, including that 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 in connection with the re-examination. The deadline for filing any such request is within 15 days of receipt of notification of the opinion.

Francesco Bellini, Neurochem's chief executive, 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. We look forward to further productive interactions with the EMEA," he concluded.