Amgen's RNAi Therapy Olpasiran (AMG 890) Designated for Breakthrough Therapy in China for ASCVD

On June 20, the CDE website showed that Amgen's RNAi therapy AMG 890 (olpasiran) is proposed to be included in the breakthrough treatment category. It is suitable for treating adult patients with atherosclerotic cardiovascular disease to reduce the risk of coronary heart disease death, myocardial infarction, and urgent coronary artery revascularization.

AMG 890 is an RNAi therapy developed by Arrowhead Pharmaceuticals that targets the asialoglycoprotein receptor (ASGPR). In September 2016, Amgen partnered with Arrowhead Pharmaceuticals in a deal worth up to $673.5 million to acquire global development and commercialization rights for AMG 890 and the RNAi ARC-LPA program.

In November 2022, Amgen published the results of the Phase II OCEAN(a)-DOSE study on AMG 890 in the NEJM journal. The study included a total of 281 patients and aimed to evaluate the efficacy and safety of olpasiran in reducing lipoprotein(a) levels in patients with cardiovascular disease compared to placebo.

The results showed that at 36 weeks, the lipoprotein(a) levels of patients in the placebo group increased by an average of 3.6%, while the lipoprotein(a) levels of patients in each dose group of AMG 890 were significantly reduced in a dose-dependent manner.

Source: NEJM

Amgen has initiated the registrational Phase III clinical trial of AMG 890 (N=6000), aiming to evaluate the impact of AMG 890 on major cardiovascular events in patients with atherosclerotic cardiovascular disease and elevated lipoprotein(a) levels. The study is expected to be completed in December 2026.

Currently, there are 28 RNAi therapies targeting ASGPR under research globally, four of which have been approved for marketing, including givosiran (Alnylam), inclisiran (Novartis), lumasiran (Alnylam), and vutrisiran (Alnylam).

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