While anticancer drugs continue to dominate the list of New Molecular Entities (NME) reaching the market, representing about a third of newly approved products in Europe in 2015, there were many other notable introductions. For example, cholesterol lowering may not seem like a new story with the success and market dominance of statins, but new mechanisms remain necessary to treat those for whom statins are ineffective.
Two competing antibodies that block the PCSK9 protein were given the go-ahead: Amgen’s evolocumab (Repatha) was followed a couple of months later by alirocumab (Praluent) from Sanofi. They are indicated for patients with high cholesterol levels who either cannot take statins, or in whom they do not work adequately. PCSK9 is involved in the regulation of the recycling of LDL receptors on the surface of liver cells, reducing the liver’s capability to clear LDL cholesterol from the blood. By blocking its activity, the PCSK9 inhibitors restore the liver’s ability to remove the unwanted cholesterol.
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