US FDA advisory panel has suggested the approval of a new, injectable cholesterol-lowering drug known as alirocumab, though many panel members have noted particular limitations for its use and have asked for additional data on the drug’s capability to decrease the risk of heart issues.
With respect to the Centers for Disease Control and Prevention (CDC), about 73 million individuals in the US have high levels of “bad” cholesterol, well-known as low-density lipoprotein (LDL). What is more, below 50% half of adults with high LDL cholesterol are getting treatment for the problem.
High cholesterol is a main risk factor for heart problems, putting people at two times the risk for the condition. Decreasing LDL cholesterol can substantially decrease the possibility of heart problems, along with the risk of heart attack and other cardiovascular problems.
Currently, a class of drugs known as statins are the standard therapy for high LDL cholesterol and have been for the last 20 years. Statins decrease levels of LDL cholesterol by interfering with an enzyme known as HMG-CoA reductase, which is accountable for cholesterol production in the liver.
On the other hand, although statins are an effective class of cholesterol-lowering medicines, they can develop a variety of side effects, which includes liver damage, digestive problems, raised blood sugar and muscle pain. Study has also related statin use to memory loss, although a latest research states this is not because of the drugs themselves.
Alirocumab (brand name Praluent) decreases LDL cholesterol by suppressing PCSK9 (proprotein convertase subtilisin/kexin type 9) – a protein that impairs the liver’s capability to remove cholesterol from the blood.
With respect to the Pharmaceutical companies – Regeneron and Sanofi – alirocumab is safer and more efficient than statins for decreasing high LDL cholesterol.
Their summary is based on the results of a phase 3 clinical program including over 5,000 sufferers with high LDL cholesterol, which includes some who are unable to tolerate statins. The results revealed a 75-mg dose of Praluent decreases LDL cholesterol by about 50 percent, while a 150-mg dose outcomes in a 60-65 percent decrease.
Committee members vote 13-3 in favor of alirocumab acceptance, but with limitations
In a meeting conducted two days back (on Tuesday 9th June, 2015), the Food and Drug Administration (FDA) advisory panel took the outcomes of the phase 3 clinical trial into account when deciding on whether to suggest approval for alirocumab as a therapy for sufferers with high LDL cholesterol.
The panel voted 13-3 in favor of alirocumab acceptance, saying that the study has confirmed that “alirocumab is well-tolerated and offers substantial decrease in LDL-C [LDL cholesterol] for a population of sufferers whose LDL-C is not properly managed with present treatments.”
However, while Regeneron and Sanofi look for approval for alirocumab as a therapy for a huge proportion of sufferers with high cholesterol, if the medicine is provided the approval by the FDA, its use may be much more limited.
Some members of the advisory panel said – depending on present data – they suggest it be used to treat sufferers with abnormally high cholesterol induced by a genetic condition well-known as familial hypercholesterolemia (FH), and they stated more information is required on its effectiveness to decreased heart problems before they can suggest its use in wider populations.
9 of the 16 panel members said they think alirocumab must be offered to sufferers at high risk of cardiovascular problems as a result of factors that cannot be managed with statins.
Only 7 panel members suggested alirocumab use for sufferers who are not able to tolerate statins because of side effects, with many of these saying the drug must be used in combo with a tolerable level of statins.
But regardless of these caveats, Regeneron and Sanofi are delighted with the result of the FDA advisory panel’s meeting.
CEO of Regeneron Dr. George D states that,
“The development of PCSK9 as a effective regulator of cholesterol levels and cardiovascular problems was one of the most significant human genetic advances of the previous decade.
Today’s result brings us one step nearer to converting this genetics-based discovery into a therapy that may assist the many sufferers in lowering additional cholesterol.”
It is approximated that if the FDA does give approval for alirocumab, the medicine would cost about $7,000-$12,000 per sufferer yearly, while brand-name statins cost about $500-$7,000 per sufferer each year.