Sun Pharma's Partner Philogen Resubmits Nidlegy MAA to EMA

Sun Pharmaceutical Industries Ltd announced that its partner, Philogen, has resubmitted the Marketing Authorization Application (MAA) for Nidlegy™ to the European Medicines Agency (EMA). Nidlegy™ is an investigational product for the neoadjuvant treatment of locally advanced, fully resectable melanoma. The updated submission includes data from a Phase III PIVOTAL study with longer patient follow-up (33 months vs. 21 months) and additional post-hoc analyses. Clinical data supporting the resubmission have been accepted for publication in the Journal of Clinical Oncology. Philogen is also addressing outstanding clinical and Chemistry, Manufacturing, and Controls (CMC) questions from the previous review. Sun Pharma has partnered with Philogen for the treatment of Skin Cancers in Europe, New Zealand, and Australia.