Submission of Nidlegy marketing authorisation application validated by EMA
The first marketing authorisation application of Nidlegy for the treatment of locally advanced fully resectable melanoma was submitted on June 3rd and validated by EMA on June 20
Philogen and Sun Pharmaceutical Industries (“Sun Pharma”) announces that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorisation Application (MAA) for Nidlegy , which was finalised on June 3 2024.
“The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, chief executive officer and chief scientific officer at Philogen. “Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need.”
Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia.
The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024.
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