Boston, MA 10/03/2014 (wallstreetpr) – Amgen, Inc. (NASDAQ:AMGN) disclosed that the Lancet published data from two Stage three trials, TESLA and RUTHERFORD-2. The data pointed out that the treatment with novel investigational low-density lipoprotein cholesterol or LDL-C, evolocumab, resulted in a statistically important reduction in LDL-C. The data compared with the placebo in patients affected by various kinds of familial hypercholesterolemia.
Inherited Condition
The Amgen, Inc. (NASDAQ:AMGN) said that Familial hypercholesterolemia was an inherited condition originated from a gene mutation that led to increased levels of LDL-C, which was also known as bad cholesterol, its statement revealed. This has the potential of a premature cardiovascular disease.
Amgen, Inc. (NASDAQ:AMGN) said that Evolocumab was an investigational completely human monoclonal antibody, which restrains proprotein convertase kexin/subtilisin type 9, a type of protein that cuts the capability of the liver to eliminate LDL-C from the blood.
Most Common Form
The company said that high cholesterol, especially elevated LDL-C, was the most family type of dyslipidemia. This was known as abnormality of fats or cholesterol in the blood. It pointed out that elevated LDL-C was considered as a big risk element for cardiovascular disease.
Management Comments
Amgen, Inc. (NASDAQ:AMGN)’s Executive VP of R&D, Sean Harper, said that the results from the two stage three trials supported the efficacy of evolocumab as a therapy option for the patients of both the types of familial hypercholesterolemia. The familial hypercholesterolemia was known for struggling to manage their cholesterol levels.
He said that it has filed submissions for evolocumab in the U.S., as well as, European Union, based on a number of other trials in its clinical study program apart from the data reported recently.
South Africa’s Witwatersrand University Lead investigator, Frederick Raal, said that results of TESLA and RUTHERFORD-2 clinical trials indicated the possibility of Evolocumab offering to deliver reduced level of LDL cholesterol. Interestingly, RUTHERFORD-2 trial evaluated 329 patients of heterozygous FH.
