Philogen Received Combination Pack Approval for Nidlegy

Publisher: The Insight Partners

Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that, on Jan. 30, 2020, EMA's CHMP expressed a favorable opinion to the request of a combination pack for the to-be-marketed pharmaceutical form of NidlegyTM, a combination of the active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). NidlegyTM is being developed as a neoadjuvant intralesional treatment for resectable Stage III melanoma patients and in locally advanced, not metastatic nonmelanoma skin cancers. NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004.

"We are extremely pleased to record EMA's agreement to our strategy for the marketing of NidlegyTM as a combination pack that was considered by CHMP 'indispensable for public health reasons,'" commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.