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Amgen (AMGN) Olpasiran Lowers Lipoprotein Levels in Phase II

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Amgen’s (AMGN - Free Report) phase II study data showed that its pipeline candidate olpasiran led to a significant, sustained reduction in lipoprotein(a) or Lp(a) levels in adults with elevated Lp(a).

In the phase II OCEAN(a)-DOSE study, the 281 study participants had an Lp(a) level of more than 150 nmol/L and atherosclerotic cardiovascular disease (ASCVD).

Amgen’s stock has risen 14.1% this year so far against a decrease of 22.1% for the industry.

 

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Elevated Lp(a) levels are strongly associated with coronary disease. High levels of lipoprotein in your blood can block arteries by sticking up to their walls, leading to heart disease and stroke. Olpasiran, a small interfering RNA molecule, has been designed in such a way that it lowers the production of apolipoprotein(a) in the body. Apolipoprotein(a) is a key component of Lp(a), which increases the risk of cardiovascular events. 

Top-line data from the study showed that olpasiran led to a significant reduction from baseline in Lp(a) of up to or greater than 90% at week 36 (primary endpoint) and week 48 (end of treatment period) for the majority of doses.

At present, no drugs/medicines are approved by the FDA to treat elevated Lp(a). Estrogen, niacin, and PCSK9 inhibitors like Amgen’s own Repatha and Sanofi’s (SNY - Free Report) Praluent are known to lower Lp(a) levels. However, Repatha and Sanofi’s Praluent are FDA approved for treating elevated LDL cholesterol levels (LDL-C) or “bad” cholesterol.

Earlier research had shown that Repatha and Praluent may lower Lp(a) to some extent. But there is no data to prove that lowering Lp(a) reduces cardiovascular disease risk.

Another PCSK9 inhibitor approved by the FDA in 2021 was Alnylam (ALNY - Free Report) and Novartis’ (NVS - Free Report) Leqvio (inclisiran) to lower LDL-C. In December 2020, Alnylam’s partner, Novartis, received marketing approval in Europe for Leqvio to treat hypercholesterolemia.

Alnylam received a milestone payment of $25 million from Novartis owing to the FDA approval of Leqvio in December 2021.

Amgen currently has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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