Statins intolerant patients in US to get PCSK9 inhibitors

Millions of patients with high cholesterol would soon have a promising an expensive new option for treatment.

The US Food and Drug Administration on Friday, approved a new type of drug to lower LDL or "bad" cholesterol. The drug, called Praluent, from Sanofi and Regeneron Pharmaceuticals Inc, comes as the first major advance in cholesterol treatment since the introduction of statins more than 20 years ago.

"This is a fantastic tool," CBS News medical contributor Dr. David Agus said on "CBS This Morning. It is a very important drug."

Praluent is the first in a new class of biotech medications called PCSK9 inhibitors and according to analysts, the drugs could generate billions of dollars in sales.

However, while the drug might offer an important alternative for patients at high risk of heart disease - especially those not capable of tolerating statins , it came at a high price - $14,600 per year.

But whether it was worth it remained a key question according to Agus.

"When you develop a new drug and you're the first out there, you have a monopoly, you can charge whatever you want and insurers and patients have to pay, especially if it can have an impact on how well and how long you live."

However, the prospect of introducing highly-expensive, injectable drugs for one of the most common medical conditions was drawing concerns from health insurers, doctors and employers, especially since generic statin pills were now available for as little as a dime a day.

Meanwhile, in addition to the new drugs, unlike statins being pricey, the statins were also proven to cut the cardiovascular risk, while it was still not settled whether the new drugs reduced serious events like heart attacks. For these reasons, many insurers planned to ask for rigorous evaluations before authorising prescriptions, to make sure patients were unable to get their cholesterol down with statins.

An estimated 10 per cent to 25 per cent of people who had tried statins reported having muscle pain, which limited the dose they could tolerate or precluded them from taking a statin at all.

According to doctors who specialised in the condition, known as statin intolerance, changing statins or trying other strategies, many patients initially considered intolerant could end up taking a statin after all - which was the aim of those who planned to aggressively challenge claims of statin intolerance.