The Food and Drug Administration have approved a new drug from Amgen Inc. on Thursday for patients that face the highest risk of heart disease.
The company won federal approval for the second drug in a new class of expensive biotech drugs that were made to reduce artery-clogging cholesterol. The new class is said to be increasingly more effective than older statin drugs used for the past decades, according to ABC News.
The drug, Repatha, is set out to help millions of Americans that are faced with extremely high risks of heart disease due to the inability to control their cholesterol with the medications available to them. And even though this new effective medication is setting new standards, the price tag is also exceeding the budgets of patients that need the medication, limiting its use.
The FDA approved the drug specifically to treat two groups of patients who face the very highest risk of heart disease that included patients with super-high levels of LDL, bad cholesterol, because of inherited conditions and those with persistently high LDL levels with a history of heart attack, stroke or other cardiovascular issues.
Amgen is based out of Thousand Oaks, California and will be announcing the new drug’s price following the FDA announcement. Another similar drug to Amgen’s new one is called Praluent which was developed by Sanofi and partner Regeneron Pharmaceuticals Inc. and approved by the FDA in late July. That drug costs $40 a day, or $14,600 per year.
At this time, since there will soon be two competing products to treat the same medical situations, employers and companies that manage the medication costs will be attempting to negotiate discounts in order to make the drug more accessible by the patients that need them.
These biologically-engineered drugs are considered to be the first huge advance in managing cholesterol levels in patients with severe conditions since the introduction of statin drugs over 20 years prior.