Neurochem Faces Kiacta Hurdle in Europe
Friday December 14, 9:17 am ET
Neurochem Gets Negative European Recommendation on Its Kidney Condition Drug Kiacta
NEW YORK (AP) -- Biotechnology company Neurochem Inc. said Friday a European advisory committee recommended against approving the company's troubled kidney condition treatment.
The drug, called Kiacta, will likely need to go through an additional study, according to the Committee for Medicinal Products for Human Use. The committee advises the European Medicines Agency and is similar to an advisory committee for the U.S. Food and Drug Administration.
Kiacta is aimed at treating Amyloid A amyloidosis, which can eventually destroy organs, including the kidneys. Half of all people diagnosed with the condition die within five years.
The FDA has twice asked the company for more information on the drug in order to consider it for approval. The agency accepted the company's latest response and a decision on the drug's status is scheduled for April 2.
Neurochem said it is considering requesting a re-examination of the European committee's opinion. If the request is made, there could be a decision by the second quarter, the company said.
surf's up......crikey
