Sun Pharma partner Philogen resubmits Nidlegy MAA to EMA
SUNPHARMA · price
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Awaiting price reaction for this filing.
Sun Pharma's partner Philogen resubmitted the Marketing Authorization Application for Nidlegy to the European Medicines Agency for neoadjuvant treatment of locally advanced, fully resectable melanoma. The updated application is based on Phase III PIVOTAL study data with 33 months median follow-up, up from 21 months, and includes additional event-free survival analyses and manufacturing information. Nidlegy is partnered with Sun Pharma for skin cancers in Europe, New Zealand and Australia.
Positive step for Sun Pharma's dermatology pipeline. No immediate revenue impact since approval is still pending review by the European Medicines Agency.