Will Amgen Inc. (NASDAQ:AMGN)’s Lipid Lowering Agent Get the USFDA Approval?
Early this week, Amgen, Inc. (NASDAQ:AMGN) announced that an experimental drug evolocumab reduced LDL cholesterol levels in patients by over 50%. The company is scheduled to release results from this late stage trial by early 2014. The patients under the trial were receiving evolocumab once a month. The drug was also not associated with any increase in side effects. However, the common side effects associated with evolocumab and standard therapy were colds, flu, upper respiratory tract infections, back pain and joint pain.
Amgen, Inc. (NASDAQ:AMGN)’s evolocumab belongs to new class of drugs known as PCSK9 inhibitors and the first data released by the company presents 52 weeks of use of this newer injectable medicines. Besides Amgen, Pfizer Inc. (NYSE:PFE) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are also engaged in advanced stages of clinical studies related to PCSK9 inhibitors. The drugs that belong to this class exert their pharmacological action by blocking a protein that prevents the liver from removing LDL cholesterol from blood.
PCSK9 inhibitors including, Amgen, Inc. (NASDAQ:AMGN)’s evolocumab, are likely to be beneficial for patients who can’t tolerate statins or those whose LDL cholesterol level remains even higher despite the high potency statin therapy. Besides LDL cholesterol, evolocumab also reduced Triglycerides by 9% and increased HDL or good cholesterol by 9%.
What USFDA Considers?
Statin like therapies that could also demonstrate a reduction in heart risk is now a days what the USFDA is generally looks for while reviewing drugs like evolocumab. Even the new cholesterol management guidelines released by the American Heart Association and American College of Cardiology also backed the similar therapy.
The USFDA’s decision that rejected Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s application for extended use of its fish oil therapy, Vascepa could be considered in this regard. Following the rejection, the USFDA in its notice to Amarin stated, “It no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.”