Amgen and Sanofi PCSK9 Drugs Can Reach U.S. Without Long Studies - (Bloomberg via NewsPoints Desk)

  • FDA deputy director Eric Colman clarified that drugmakers that are developing PCSK9 inhibitors, including Amgen, Pfizer and Sanofi, will not be required to demonstrate that their therapies reduce the risk of heart attack and death to garner regulatory approval, Bloomberg reported Thursday.
  • Earlier this week, analysts questioned whether US and European regulators would be willing to approve these experimental therapies after new guidelines were issued by the American Heart Association and the American College of Cardiology.
  • An FDA approval decision for cholesterol-lowering therapies "will be based on the compound's effects on the entire lipoprotein lipid panel, particularly LDL-cholesterol, its effects on other markers of potential cardiovascular risk," Colman remarked.
  • The new guidelines recommend expanded use of statins such as Pfizer's Lipitor and AstraZeneca's Crestor, while therapies that work through other mechanisms, including Merck's Zetia and Vytorin, were not backed for use.
  • Eli Lilly, Roche and Alnylam Pharmaceuticals are also among the pharmaceutical companies developing PCSK9 inhibitors.
  • Colman noted that the ongoing Improve-It trial of Vytorin could change the agency's approach if the results fail to prove that the drug's cholesterol-lowering effects translate into reduced risks of death and heart attack.

To read more NewsPoints articles, click here.