Corporate News     04-Jul-24
European Medicines Agency validates submission of MAA for Nidlegy™
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.

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