Neurochem gets FDA approvable letter for eprodisate, additional data requested

By Elaine Rigoli

Tampa, Fla., Aug. 11 - Neurochem, Inc. has received an approvable letter from the Food and Drug Administration for eprodisate (Kiacta - formerly Fibrillex) for the treatment of Amyloid A amyloidosis.

In its action letter, the FDA requested additional efficacy information, as well as a safety update. The FDA stated that this efficacy information would probably need to be addressed by one or more additional clinical trials. As an alternative, the FDA also stated that significant findings obtained from a complete follow-up of patients in the existing study could be persuasive.

"We are working closely with the agency to secure as soon as possible the final approval without conducting a new efficacy clinical trial. We are already starting to collect additional information as suggested by the FDA," chairman, president and chief executive officer Francesco Bellini said in a news release.

Amyloid A amyloidosis is a progressive and fatal condition in which amyloid proteins build up in the body's organs. Symptoms may include gastrointestinal complications such as chronic diarrhea and malabsorption, enlargement of the liver or spleen and kidney failure. The condition occurs in a proportion of patients with chronic inflammatory disorders, chronic infections and inherited diseases such as Familial Mediterranean Fever, the release said.

Neurochem is a pharmaceutical company based in Laval, Quebec.

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