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06/05/16
15:48
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Originally posted by TDA
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Hmmm??:
REGN EC:
"In March we reported positive data from the Phase 3 ODYSSEY ESCAPE study in patients with heterozygous familial hypercholesterolemia who required chronic weekly or bi-weekly apheresis. Apheresis is an invasive, expensive and time-consuming therapy given to the patients with the highest cholesterol levels and the greatest need. Our studies show that Praluent reduced the need for apheresis by 75% compared to placebo and 63% of Praluent patients no longer required apheresis compared to 0% of the patients in the placebo arm. Praluent is the only PCSK9 inhibitor that has been studied in this apheresis setting, which represents some of the most severe hypercholesterolemic patients.
The adverse events that occurred more frequently in the Praluent-treated patients were injection site reactions and myalgia. We expect our Supplemental BLA for the once-monthly dosing regimen of Praluent to be filed in the second quarter, which, if approved, will expand our dosing flexibility options "
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"Heterozygous FH (HeFH). HeFH occurs in 1 in 250 people worldwide." ...
"In the United States alone, an estimated 1.3 million people live with FH. Yet only 10% of them are diagnosed ."
https://thefhfoundation.org/about-fh/what-is-fh/
Can't wait for all those adds telling people to ask your doctor if you have HeFH.