Amgen Scores Again with PCSK9 Inhibitor


Amgen (AMGN) continues to present positive data on its PCSK9 inhibitor, evolocumab. The company said that evolocumab achieved the primary endpoint of lowering bad cholesterol (low-density lipoprotein cholesterol (LDL-C)) in patients suffering from homozygous familial hypercholesterolemia (HoFH).

HoFH is a rare genetic disease characterized by significantly high LDL-C levels which increase cardiovascular risk in these patients, who are mostly affected from an early age.

Results from the phase III TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) study showed a clinically meaningful and statistically significant reduction in bad cholesterol compared to placebo (at week 12).

Amgen said that safety was generally balanced across the treatment groups with the most common adverse events in the evolocumab group being upper respiratory tract infection, influenza, gastroenteritis and nasopharyngitis.

Amgen has been consistently providing positive data on evolocumab which works by inhibiting PCSK9, a protein that cuts the liver's ability to remove LDL-C from the blood. Apart from the TESLA data, Amgen has presented positive data on evolocumab from five other phase III studies on other patient populations. Amgen pointed out that the TESLA results are the first phase III data on a PCSK9 Inhibitor in HoFH patients.

The positive evolocumab data comes on the heels of encouraging data on Amgen’s phase III oncology candidate, talimogene laherparepvec. A retrospective analysis of patients with metastatic melanoma showed that talimogene laherparepvec reduced the size of injected as well as non-injected tumors that had metastasized to other parts of the body.

Amgen is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the biotech sector include Gilead Sciences Inc. (GILD), Alexion Pharmaceuticals, Inc. (ALXN) and Alkermes plc (ALKS). All three carry a Zacks Rank #1 (Strong Buy).

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