EMA validates Philogen and Sun Pharma’s MAA for melanoma
Source: Pharmaceutical Technology, July 2024
The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma.
Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma.
The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial.