Isis Preps To Advance Two Drugs To Phase III In Rare Diseases
Isis will target its APOCIII candidate to treat extremely and severely high triglycerides first, then move to broader populations. The strategy harkens back to the plan for cholesterol drug Kynamro, which has had a slow launch.
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With cheap, proven statins aplenty, cost constraints are “off the table” when it comes to vastly broadening primary prevention, authors of new cholesterol guidelines say at the 2013 AHA meeting. However, evidence for drugs to lower triglycerides and boost HDL is lacking, and focus should be on lifestyle change, they say.
The RNA interference-focused biotech will bring the rest of its pipeline forward with subcutaneous technology now that it has been validated in human studies, but the company will continue to pursue approval of its lead candidate as an infusion product.
Genzyme said it is ready to deliver product, but complying with the REMS that helped pave the way for approval is a time-limiting factor for launching the familial hypercholesterolemia drug. Drug will be priced at $176,000 per year, significantly lower than Aegerion’s competing Juxtapid.