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news.Neurochem has initiated the submission of a rolling new drug application to the FDA seeking marketing approval for its investigational drug, Fibrillex, for the treatment of the fatal inflammation-related disease, AA Amyloidosis.
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In 1999, Fibrillex received US orphan drug designation, which will give the product seven years of market exclusivity upon FDA approval. Neurochem plans to complete the submission of the new drug application (NDA) around year-end.
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with chronic inflammatory diseases, including rheumatoid arthritis. No specific treatment is currently available for the condition and the goal of existing therapies is limited to controlling the underlying chronic inflammatory disease.
“We are pleased to report that we have initiated the submission of our NDA for review ahead of schedule,” said Dr Denis Garceau, Neurochem’s senior vice president of drug development. “Fibrillex appears to delay the progression of renal disease and to be well tolerated. To date, the results from the phase II/III clinical trial have been well received by the physicians.”
Neurochem shares a collaboration and distribution agreement for Fibrillex with Centocor, a Johnson & Johnson company.