Sun Pharmaceutical Submits Nidlegy™ MAA to EMA for Neoadjuvant Melanoma Treatment

Philogen S.p.A. and Sun Pharmaceutical Industries Limited have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy™, an investigational treatment for neoadjuvant (i.e., prior to surgery) locally advanced fully resectable melanoma. The submission was based on clinical data from the Phase 3 PIVOTAL study and a Phase 2 trial. Nidlegy™, given intralesionally for 4 weeks, acts by boosting the immune system against neoplastic lesions. In the PIVOTAL trial, Nidlegy™ reduced the risk of relapse or death by 41% compared to the control arm.