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May 17, 2021

LoA Update: United Therapeutics’ Unituxin for osteosarcoma tumbles 12 points in FDA regulatory potential after NCI-sponsored Phase II results

As of 11 May, the Likelihood of Approval (LoA) for United Therapeutics’ (NASDAQ:UTHR) Unituxin (dinutuximab) for osteosarcoma dropped 12 points, according to GlobalData’s LoA data.

By William Newton

As of 11 May, the Likelihood of Approval (LoA) for United Therapeutics’ (NASDAQ:UTHR) Unituxin (dinutuximab) for osteosarcoma dropped 12 points, according to GlobalData’s LoA data. This news is the result of a Phase II trial, sponsored by the National Cancer Institute (NCI), that showed Unituxin was ineffective in patients with recurrent osteosarcoma, in a 7 May update to ClinicalTrials.gov.

Though 41 patients enrolled in the Phase II, 32 did not complete the study, including 28 patients who dropped out due to a lack of efficacy, according to ClinicalTrials.gov. In addition, 30.77% of patients experienced serious adverse events, including eye disorders and vomiting. Unituxin previously received FDA approval for treating neuroblastoma in March 2015 and had sales of $123m in 2020 for that indication, according to GlobalData.

While the LoA prior to this news was 15%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has dropped the LoA to 3%. Unituxin is an intravenously administered monoclonal antibody.

United Therapeutics has a market cap of $8.68bn.

William Newton is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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