Neurochem gets priority review for eprodisate

By Elaine Rigoli

Tampa, Fla., April 18 - Neurochem (International) Ltd. said its New Drug Application for eprodisate (Fibrillex) for the treatment of Amyloid A (AA) amyloidosis has been filed and granted priority review by the Food and Drug Administration.

The FDA priority review designation establishes a target six-month review period from the date of receipt of the application, the company said in a news release.

The FDA is expected to render a decision on the approvability of eprodisate Aug. 13, 2006, the release said.

In a phase 2/3 clinical trial, eprodisate was investigated to evaluate its safety and efficacy in patients with AA amyloidosis, a disease that Neurochem said affects close to 17,000 people in the United States.

Currently, there is no FDA-approved therapy to treat AA amyloidosis, a condition that normally progresses to end-stage renal disease, dialysis and ultimately death.

Over its development, eprodisate received orphan-drug designation and fast-track status by the FDA and was accepted by the Agency for the Continuous Marketing Application pilot 1 and 2 programs.

In December 2004, Neurochem signed a definitive collaboration and distribution agreement, granting Centocor, Inc. of Malvern, Pa., a wholly owned subsidiary of Johnson & Johnson, exclusive distribution rights for eprodisate worldwide, with the exception of Canada, Switzerland, Japan, China, South Korea and Taiwan.

Based in Ecublens, Switzerland, Neurochem is focused on the development and commercialization of therapeutics to address critical unmet medical needs.

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