Italian drugmaker Philogen (BIT: PHIL) has announced its decision to voluntarily withdraw the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy(daromun), a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma.
The Marketing Authorization Application (MAA) for Nidlegy, which was filed with partner Indian drugmaker Sun Pharmaceutical Industries (BSE: 524715) a year ago, was supported by data from PIVOTAL (NCT02938299), 0a randomized Phase III study in 256 patients with locally advanced fully resectable melanoma, in which Nidlegy reduced the risk of relapse or death by 41% compared to the control arm. The safety profile of Nidlegy™ was characterized mostly by low-grade, local adverse events.
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls (CMC) and additional clinical data to better characterize the benefit:risk profile in patients with locally advanced resectable melanoma. Provision of the CMC and clinical data were unlikely to be completed within the current allowed timeframe.
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