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Author: NailThatJello Big gold star, 5000 posts Ticker Guide Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 30418  
Subject: Rare Mutation Ignites Race for Cholesterol Drug Date: 7/10/2013 2:34 AM
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A new breakthrough in LDL cholesterol management.

Despite major gains over the past half-century, heart disease remains the leading killer of Americans, causing nearly 600,000 deaths a year. A fevered race is underway among three pharmaceutical companies, Amgen, Pfizer and Sanofi, to test and win approval for a drug that drives LDL levels to new lows and prevents heart attacks. All three companies have drugs in clinical trials and report that their results, so far, are exciting.

So far people with stubbornly high cholesterol levels who are taking the drugs in preliminary studies have seen their LDL levels plunging from levels well over 100 to 50, 40, or even lower.

Like insulin for diabetes, the drugs are injected, but they are taken once or twice a month.

The story of how these drugs came about began a decade ago. The cause of a family’s misfortune with astonishingly high LDL levels — up to 466 — and a strong history of heart disease turned out to be a mutation in a gene called PCSK9, whose function was unknown. [That led to finding mutants of the gene that] led to very low levels of LDL and protected against heart disease. Those who had even a single mutated gene seemed almost immune to heart disease, even though many had risk factors, including high blood pressure, diabetes and smoking.

The prospect of a drug to create the effects of the mutations “was so hot it sizzled,” said Dr. Steven Nissen, leader of an Amgen trial. Amgen has readied three factories, in Colorado, Puerto Rico and Rhode Island, to make its drug. It is anticipating production on a scale never attempted before with a monoclonal antibody.

http://www.nytimes.com/2013/07/10/health/rare-mutation-promp...
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