BioCentury
ARTICLE | Clinical News

APF530 regulatory update

April 1, 2013 7:00 AM UTC

A.P. Pharma said FDA issued a second complete response letter for an NDA for APF530 to prevent chemotherapy-induced nausea and vomiting (CINV). According to the company, FDA did not request new clinical studies, but did ask the company to conduct a re-analysis of Phase III data that reclassifies patients into those receiving moderately emetogenic chemotherapy and highly emetogenic chemotherapy according to recently modified American Society of Clinical Oncology (ASCO) 2011 guidelines. FDA also requested a human factors validation study to evaluate the usability of the APF530 syringe system with its proposed product labeling and instructions; the company to address certain deficiencies identified during an FDA inspection of manufacturing facilities; and refinement of a product quality analytical test method. The company believes it can address the issues raised in the response and expects the letter to delay the product launch to 1H14 from 2H13. ...