After Wednesday’s recommendations that US regulators approve new and more effective anti-cholesterol medication, the FDA approved Sanofi and Regeneron’s alirocumab as well as Amgen’s evolocumab.
The vote on evolocumab’s benefits to risks ratio ended 11 to 4 and the advisory panel decided that the drug should be approved. Similarly, the same advisory panel then discussed Sanofi and Regeneron’s alirocumab, which was also approved after a 13 to 3 vote.
Although the Food and Drug Administration isn’t required to follow the advice of the panel, it most often does.
The two major players in Wednesday’s discussions, alirocumab and evolumab, work differently than other cholesterol-lowering medication currently on the market. Both alirocumab and evolocumab act by blocking a specific gene in the liver known as PCSK9. As a result of its action, LDL-cholesterol (low-density lipoprotein cholesterol, also known as bad cholesterol) plummets.
Such abrupt drops in cholesterol levels (as much as 65 percent) are accompanied by little to no side effects, clinical trials have shown. In fact, during trials, the side effects experienced by patients were similar to those seen with placebos.
The panel did have some additional recommendations, though. The immediate use of Regeneron’s Praulent should only involve those patients whose high cholesterol levels are caused by genetic conditions such as hypercholesterolemia.
Evolumab and alirocumab aren’t administered as pills. They come in injectable form and are administered monthly or bi-monthly, depending on the patient’s treatment plan and the drug’s formulation.
Studies are still being conducted in respects to heart disease reduction and life expectancy increases and the results will only be available in 2017. Even so, pharmaceutical companies are convinced that the new compounds are capable of improving the lives of close to 11 million Americans.
The advisory panel recommended a “cautious optimism” where the new drugs are concerned, especially since the data already obtained from trials is exciting but not revealing enough.
Most importantly, trials have not completely ruled out the potential side-effects that the drugs may have. In certain clinical trials, patients incriminated confusion and attention deficits as side effects of the treatment. And it’s precisely these neurocognitive effects that further research has to rule out.
Alirocumab and evolumab represent a viable alternative for those patients unable to undergo statin treatment. Some patients experience intolerable muscle pains while others cannot take statins because of hard-to-manage diabetes and such patients are ideal candidates for PCSK9 treatment.
Moreover, patients suffering from genetic disorders such as familial hypercholesterolemia could also benefit from the treatment.
Treatment with the two compounds does come with a hefty price tag: a patient would be looking at annual costs of approximately $10,000.
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