Self-injectable cholesterol drug alirocumab is in the pipeline

Pharmaceutical giants Sanofi and Regeneron have developed a potentially ground-breaking new cholesterol drug – currently named ‘alirocumab’ – which analysts are predicting could be a massive sensation and bring in billions of dollars for its creators if the late-stage trials prove successful.

The new cholesterol-lowering drug is self-injectable and belongs to a class of biotech medicines named PCSK9 inhibitors, providing a different method of clearing the fatty deposits that can cause clogging within the arterial walls leading the way to a high risk of poor health, heart disease, strokes and other health complications.

Bad cholesterol, commonly referred to as “low density lipoprotein,” is one of the primary factors behind clogged arteries. If your body is generating sufficient amounts of good cholesterol, or “high density lipoprotein,” this helps the bad cholesterol to be cleared from the arterial walls and subsequently removed from the bloodstream via the liver. However, if you are low on good cholesterol, levels of bad cholesterol will rise and result in clogging in the arterial walls.

Health experts believe that PCSK9 inhibitors could be the biggest breakthrough in the fight against heart disease in two decades, since statins such as Lipitor, Crestor and Zocor have emerged.

Alirocumab contains man-made antibodies that target a particular protein which stops the body from getting rid of the bad LDL cholesterol from the bloodstream. They differ from the statins as statins actually prevent the liver’s production of LDL cholesterol.

Results from the new drug tested in a 100-patient trial are imminent and Sanofi are hopeful it may reach the market in two years’ time. Unfortunately, success will probably hinder on the results of more long-term clinical studies comprising on thousands of patients – and more reliable and trusted results will probably not be available for another five years from such studies.

Following tests in the initial Phase III study, alirocumab was found to reduce levels of LDL cholesterol by up to an incredible 72% and it is now being pitted against Merck’s Zetia, which has been shown to lower LDL cholesterol levels by around 19-24%.

Alirocumab is likely be prescribed to those with genetically-high cholesterol levels, patients deemed ‘high risk’ and who are not reaching cholesterol targets on whichever statin they are taking, and patients who could have a low tolerance to statins.

Speaking at a conference earlier this month, Sanofi’s CEO Chris Viehbacher said the French drugmaker may consider doubling its stake in Regeneron, clearing having faith in the ability and success of alirocumab.

He commented: “When you look at the number of patients who are willing to inject themselves daily for diabetes, and you know a lot of those patients are also going to be in your patient population for PCSK9, I actually think that the injectable part is not going to be as big a barrier as people think. I think it is going to be a paradigm shift for healthcare and a potentially huge opportunity for us.”

Unfortunately, the need for alirocumab to be injected and the high costs involved will deter many and pricing will be a major issue in the UK as the NHS already facing numerous deficit-cutting measures. Certainly the new drug, if and when it eventually hits the market, will be substantially more expensive than statins – currently prescribed to around 7 million people in the UK.