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Sun Pharmaceutical Industries Limited and Philogen SpA announced they have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Nidlegy, an investigational treatment for locally advanced, fully resectable melanoma in the neoadjuvant setting. The submission is based on clinical data from phase 3 pivotal study and phase 2 trial. The approval would grant marketing authorisation for Nidlegy, an immunocytokine product.
Dario Neri, CEO and CSO of Philogen, said, “This disease is currently managed with surgery, potentially followed by systemic adjuvant therapies that are potentially given for years. Having access to a short, well tolerated, and fast-acting therapeutic intervention like Nidlegy represents a major advance for patients.”
The company also said that Nidlegy is part of a partnership between Philogen and Sun Pharma for the treatment of skin cancers in Europe, New Zealand, and Australia. The companies previously announced that the phase 3 pivotal trial met its primary endpoint of recurrence-free survival.
The shares were down by 0.24 per cent to ₹1,449 at 12.55 pm on the BSE.
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