FDA CRL - Nanocopoeia, LLC

The U.S. FDA issued a Complete Response Letter to Nanocopoeia, LLC regarding its New Drug Application (NDA 217379) for nilotinib orally disintegrating tablets. The application cannot be approved in its current state due to significant deficiencies.

A central issue lies in Clinical Pharmacology, where a pivotal bioequivalence study failed to demonstrate equivalency between the proposed nilotinib ODT and the reference drug, Tasigna. The ODT exhibited a 34% higher maximum concentration (Cmax), raising safety concerns, particularly regarding potential QT prolongation, which was observed in subjects receiving the ODT. Nanocopoeia must conduct a new study to confirm bioequivalence and thoroughly characterize the QT prolongation risk.

Furthermore, a pre-approval inspection of a manufacturing facility identified deficiencies, requiring satisfactory responses to the FDA Form 483. The FDA also reserved comment on the proposed prescribing information and carton/container labeling until other issues are resolved, but mandated adding specific language to the Medication Guide. The conditionally accepted proprietary name requires resubmission after all deficiencies are addressed.

Required actions include a comprehensive safety update, incorporating all new clinical and nonclinical data, detailed adverse event analysis, and worldwide safety experience. Nanocopoeia has one year to submit a complete response addressing all identified deficiencies.