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Philogen and Sun Pharma: EMA Validates Nidlegy Marketing Authorization Application for Skin Cancer Treatment

NextEdge Admin

04 Jul 2024

2 min 46 sec

Philogen S.p.A. (BITHIL) and Sun Pharmaceutical Industries Limited have reached a significant milestone with the European Medicines Agency (EMA) validating the Marketing Authorization Application (MAA) submission for Nidlegy on June 20th. Developed by Philogen, Nidlegy is a biopharmaceutical aimed at treating skin cancers. It combines two active ingredients, L19IL2 and L19TNF, designed to target tumors with minimal impact on healthy tissues.

Nidlegy's validation by EMA marks a pivotal step in its regulatory journey, allowing for further review towards potential approval. Dario Neri, CEO and CSO at Philogen, emphasized their commitment to collaborating with EMA to make Nidlegy accessible to patients in need. The drug, partnered with Sun Pharma, targets European, New Zealand, and Australian markets for skin cancer treatment.

Clinical trials are underway to assess Nidlegy's efficacy across different cancer types. Phase III trials include PIVOTAL, an international study evaluating its use as a neoadjuvant treatment in locally advanced melanoma. This study involves 256 patients across Europe and aims to demonstrate the drug's efficacy in combination with standard-of-care treatments, such as surgery.

Melanoma, characterized by uncontrolled growth of melanocytes, presents challenges in treatment, particularly in advanced stages. Nidlegy's approach leverages specific antibodies and pro-inflammatory cytokines to target tumor cells effectively, potentially improving outcomes for patients with resectable melanoma.

Philogen, an Italian-Swiss biotech firm, specializes in innovative cancer treatments utilizing targeted delivery mechanisms to minimize side effects on healthy tissues. Sun Pharma, a leader in specialty generics globally, brings extensive expertise to the partnership, enhancing Nidlegy's market potential and accessibility.

With ongoing clinical trials and regulatory milestones achieved, Nidlegy represents a promising advancement in the field of oncology, offering hope for improved treatment options in skin cancer, particularly melanoma.