Esperion announced positive results today for the first in a series of pivotal phase 3 studies of its cholesterol lowering drug. The trial (Study 4, or 1002-048) compared bempedoic acid to placebo in 269 patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD who have high LDL cholesterol levels (100 mg/dl or greater)…
Novel Cholesterol Therapy Flops And Company Ends Development
November 8, 2016 by Leave a Comment
–13 years after ApoA-1 Milano sparked excitement the novel HDL therapy appears to be dead. After 13 years and despite the efforts of 3 separate companies, the novel cholesterol therapy known as ApoA-1 Milano appears to be dead. On Monday afternoon the Medicines Company announced that it had discontinued development of the drug and would…
Novel Cholesterol Drugs Move Forward In Clinical Trials
October 18, 2016 by 1 Comment
–New information about upcoming cholesterol drugs from the Medicines Company and Esperion Recently the makers of two novel cholesterol-lowering drugs in development provided important updates on their progress. On Tuesday, the Medicines Company announced positive top-line results for a trial of its unusual PCSK9 synthesis inhibitor scheduled to be presented in November. Last week Esperion…
FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug
June 30, 2016 by Leave a Comment
Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within…
No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year
February 18, 2015 by Leave a Comment
In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case…. … Click here to read the full post on Forbes. …
Slouching Toward Phase 3: Progress Report On New Cholesterol Drugs At The AHA
November 25, 2013 by Leave a Comment
The American Heart Association meeting in Dallas this year brought new phase 2 data about several promising new cholesterol drugs. But before jumping on any bandwagons it would be good to remember that even for the drugs most far along in development we still haven’t seen any phase 3 data. In addition, it bears repeating that the…
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