The FDA priority review designation establishes a target six-month review period from the date of receipt of the Fibrillex (eprodisate) NDA.
Priority review is granted to product candidates that would offer a significant improvement in the treatment, diagnosis or prevention of the disease or that address an unmet medical need.
In a phase II/III clinical trial, Fibrillex was investigated to evaluate its safety and efficacy in patients with AA amyloidosis, a disease that is believed to affect close to 17,000 people in the US. Currently, there is no FDA-approved therapy to treat the disease.
“This priority review acknowledges the need for a new medicine, potentially Fibrillex, to provide a therapeutic solution for this serious illness,” said Dr Denis Garceau, Neurochem’s senior vice president of drug development. “We look forward to continuing to work closely with the FDA as it reviews the NDA.”