Amgen Inc. AMGN presented encouraging one-year data from the phase II (OSLER-1) and phase III (OSLER-2) open-label extension studies and phase III YUKAWA-2 study on its PCSK9 inhibitor, Repatha (evolocumab), at the American College of Cardiology’s Annual Scientific Session.
Repatha works by inhibiting PCSK9, a protein that lowers the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C) or “bad” cholesterol from the blood.
The ongoing open-label OSLER-1 and OSLER-2 extension studies, being conducted to evaluate the long-term effects of Repatha, revealed that the candidate in combination with standard of care (SOC) treatment reduced adjudicated cardiovascular complications (0.95%) compared to SOC alone (2.18%) over a period of one year.
Moreover, Repatha plus SOC resulted in a 61% reduction in LDL-C when compared to SOC. Additionally, data from the OSLER-1 study showed that Repatha maintained its efficacy over a period of two years with no safety risk being identified. Results from OSLER studies were also published in the New England Journal of Medicine.
Meanwhile, results from the phase III YUKAWA-2 study demonstrated that subcutaneous doses of Repatha (140 mg every two weeks or 420 mg monthly) in combination with different daily doses of Lipitor (atorvastatin) reduced LDL-C by 67%-76% compared to placebo. The study was conducted in Japanese patients with high cardiovascular risk and high cholesterol.
Based on encouraging data, Amgen intends to seek approval in Japan. We remind investors that Repatha is currently under review both in the U.S. (response expected by Aug 27) and EU.
We believe that Repatha has huge market potential. However, companies like Regeneron REGN and Sanofi SNY have also reported encouraging data from their phase III study (ODYSSEY LONG TERM) on PCSK9 antibody, Praluent. Praluent is currently under priority review with a response from the FDA expected by Jul 24.
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Acorda Therapeutics, Inc. ACOR carrying a Zacks Rank #1 (Strong Buy).
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