Submission of Nidlegy™ Marketing Authorization Application Validated by EMA


The first marketing authorization application of Nidlegy™ for the treatment of locally advanced fully

resectable melanoma was submitted on June 3rd and validated by EMA on June 20

The assessment period of the dossier by the authorities has started on June 20th 

Siena, Italy, and Mumbai, July 4: Philogen S.p.A. (BIT:PHIL) and Sun Pharmaceutical Industries Limited  announces that on June 20th the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy™ , which was finalized on June 3rd .

“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. Both companies jointly made the following announcements: –

October 23, 2023 – Phase III PIVOTAL trial met the primary endpoint 

May 31, 2024 – Primary results of PIVOTAL presented at ASCO 

June 4, 2024 – MAA submission to EMA

The data of the Phase III Nidlegy™ trial are expected to be published in a peer-reviewed scientific journal in 2024