On Friday, the FDA announced that it has approved the cholesterol lowering drug alirocumab, a drug marketed under the brand name of Praluent.
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Praluent, which is developed by Regeneron Pharmaceuticals Inc. and Sanofi SA, as reported in the Wall Street Journal, will be the first drug of its class, the proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor, in the country. Many patients do not achieve their physicians’ recommended lower levels of high LDL, or bad, cholesterol despite dietary and lifestyle changes and use of standard cholesterol-reducing drugs, according to Praluent’s developers. It is also approved for patients with clinical atherosclerotic cardiovascular disease, such as those who have had a stroke or heart attack.
However, Regeneron and Sanofi came to Praluent’s defense stating that the drug costs a lot less than other drugs administered in similar ways, such as autoimmune drugs Humira and Enbrel, which thousands of patients use and cost over $38,000 a year. “It focuses on those who’ve truly had clinical disease or those who start out with such high levels of LDL they can’t get anywhere near where they should be and I think those are the most at-risk people”, said Dr. Donald A. Smith, associate professor of medicine and cardiology at Mount Sinai Hospital in New York.
However, the high price of the drug at $40 is expected to trigger a debate anytime soon as it could also be of concern to health insurers, employers and doctors. Payers are likely to restrict access to only a small group of their patients that have already exhausted their use of statins, as generic forms of statins cost a tiny fraction of Praluent’s list price. There are now seven of these medicines on the market.
As with most medications, the drug has some potential side effects, including itching, swelling, pain or bruising from the injection.
Approval of this drug makes another treatment option available for patients who are not experiencing any improvement even after being treated with existing medications.
In limiting its sanction to the slimmer affected person human population the FDA followed recommended of participants in its ifa solar panel, who might in June suggested its try be exclusively for the ones who…
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In over 20 years, this is the first time ever that a major advancement in conditions related to cholesterol has been approved after the statin drugs were discovered and several analysts believe that Praulent can generate several billions of revenue.
