Philogen S.p.A. and Sun Pharmaceutical Industries announced that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy™ , which was finalized on 03 June 2024.
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:
- 23 October 2023 - Phase III PIVOTAL trial met the primary endpoint
- 31 May 2024 – Primary results of PIVOTAL presented at ASCO
- 04 June 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.