Cadence Reports Priority Review, Acceptance Of NDA Submission For Acetavance
Acetavance is intended for the treatment of acute pain and fever
Cadence's New Drug Application (NDA) for Acetavance (intravenous acetaminophen) has been accepted for filing by the FDA, and is designated for Priority Review. The drug will be used for the treatment of acute pain and fever in adults and children.
The company said that the Priority Review designation reduces the target review period for NDA, from ten months to six months. Acceptance of the NDA submission indicates that FDA has made a threshold determination that its NDA is sufficiently complete to permit a substantive review. .
The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents. It also includes data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen, in countries outside the US.
Ted Schroeder, president and CEO of Cadence, said: We are very pleased with the FDA's decision to grant the Acetavance NDA a Priority Review, which we believe reflects the potential of Acetavance to fulfill a significant unmet need for a new class of intravenous medication to treat acute pain and fever in adults and children, for which there remains a large gap in the US treatment paradigm.
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