Amgen Inc announced their experimental new type of cholesterol-fighting injectable drug evolocumab has been able to meet its primary goal. It registered success by reducing 'bad' LDL cholesterol in patients having a genetic tendency of having high levels of the artery-clogging fat.
A late-stage trial of the drug also known as AMG-145 was carried out. Amgen said the drug given once a month along with daily statin treatment proved showed improvements among patients in comparison to patients taking statins alone after 12 weeks of treatment.
The Phase 3 study, called TESLA, had 49 adults and adolescent patients having a rare condition called homozygous familial hypercholesterolemia. The condition is so rare that it is seen in about one in a million people. But it can lead to a four-fold increase in levels of LDL cholesterol that increases the risk of heart disease.
The drug evolocumab blocks PCSK9, a naturally occurring protein that keep LDL levels high in the blood stream. Amgen said the safety risk was found to be similar among those taking evolocumab along with statins and those taking statins alone.
Most common side effects were upper respiratory tract infection, stuffy nose and gastrointestinal inflammation. Amgen is not alone when it comes to coming up with new drugs targeting PCSK9, as Pfizer Inc and a partnership between Regeneron Inc and Sanofi are also doing trials of anti-PCSK9 antibodies.
The PCSK9 inhibitors is now said to be one of the most closely followed new classes of medicines, said Richard Purkiss, an analyst with Atlantic Equities. If these drugs get green signal then they would be allowed to be taken by very high-risk patients who despite taking statin treatment have frustrating high LDL.