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May 10, 2021

LoA Update: Amgen’s Nplate in aplastic anemia soars 11 points in FDA likelihood of approval after posting strong trial results

The FDA Likelihood of Approval (LoA) for Amgen’s Nplate (romiplostim) in aplastic anaemia jumped 11 points as of 22 April, according to GlobalData’s LoA analysis.

By Sean Rai-Roche

The FDA Likelihood of Approval (LoA) for Amgen’s Nplate (romiplostim) in aplastic anaemia jumped 11 points as of 22 April, according to GlobalData’s LoA analysis. The update comes after Amgen posted positive trial results in January, which showed the vast majority of participants displayed a haematological response.

While Nplate previously had an LoA of 63%, this rose to 74% after the results, as determined via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. The Phase II/III open-label study (NCT02773290) had a primary endpoint of patients achieving any haematological response at week 27, which was met by 84% of participants. At that point, there were marked improvements in platelet response (65%), erythrocyte response (74%), neutrophil response (39%), and trilineage response (26%). Nplate was also well-tolerated, with the most common safety events being nasopharyngitis (42%), upper respiratory tract infection (26%), pyrexia (19%), headache (16%), diarrhoea (13%) and muscle spasms (13%) (Jang, JH, et al. Br J Haematol. 2021 Jan; 192(1): 190–199).

Nplate was evaluated in 31 patients in Japan and Korea with aplastic anaemia who were refractory to immunosuppressive therapy (IST) and thrombocytopenia. Participants were administered with Nplate subcutaneously at a fixed dose of 10µg/kg once a week for four weeks, followed by doses of 5, 10, 15 and 20µg/kg once weekly up to 52 weeks.

Sean Rai-Roche 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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