Amgen files first-in-class cholesterol drug with FDA
- Amgen has created a very large clinical trial program for evolocumab consisting of 10 individual clinical trials, with data from more than 6,800 patients, including 4500 patients with hypercholesterolemia.
- Based on clinical trial data, evolocumab has shown efficacy across a broad range of patients, including those with refractory hypercholesterolemia, those who are intolerant of statins, and patients with hypercholesterolemia due to rare genetic disorders.
- Sanofi/Regeneron is also developing a PCSK9 inhibitor to treat hypercholesterolemia. The race is on to see which company’s product will be approved first.
Amgen is widely expected to receive priority review status for evolocumab. As part of the new class of PCSK9 inhibitors, evolocumab inhibits the actions of a protein that reduces the liver’s ability to remove bad cholesterol from the blood.
According to Amgen’s R&D chief, Sean Harper, Amgen plans to file evolocumab in different markets. Despite the fact that there are numerous treatment options for hypercholesterolemia, many patients remain poorly controlled. The market potential for this class of drugs is huge, with some analysts predicting global sales as high as $1.404 billion by 2019.
- Pharma Times Amgen files cholesterol drug evolocumab in USA