FDA renews demand for more data on Kiacta

Analysts were left scratching their heads trying to determine if the FDA's second approvable letter for Neurochem's amyloidosis therapy Kiacta helped or hurt the company. The agency said that there was some efficacy data from Phase II and III but that more efficacy data would be needed for approval. The agency also said that new data submissions and pharmacokinetic studies could eliminate a requirement for a new trial. Amyloidosis is a rare disease characterized by the buildup of amyloid proteins in the body. Neurochem says it is preparing a consolidated efficacy report which it plans to submit in two months. But analysts were divided over whether the company could gain an approval without an entirely new trial--which could doom the drug.

- read the AP report

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