EMA validates submission of Marketing Authorization Application for skin cancer treatment Nidlegy: Sun Pharma, Philogen

Mumbai: Sun Pharmaceutical Industries Limited and Philogen S.p.A. have announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy on June 20th, 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.

Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF. The two ingredients are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with a potent anti-tumor activity. Nidlegy is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

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

Read also: Sun Pharma, Philogen seek EMA marketing nod for skin cancer treatment Nidlegy