Approval by the Food and Drug Administration of the new PCSK9 inhibitors would be an enormous boon to the drugmakers that developed them.
According to Karen Andersen, a senior analyst covering biotechnology for Morningstar, a Chicago-based independent investment-research firm, here's what's at stake for the manufacturers seeking FDA approval of the new drugs.
Paris-based Sanofi is partnering with Tarrytown, N.Y.-based Regeneron Pharmaceuticals to develop alirocumab. Sanofi has been “struggling for growth,” Andersen said. Its patent on Lantus, a top-selling insulin with more than $7 billion in sales worldwide in 2014, runs out this year, with makers of biosimilars itching to challenge its franchise.
“They're seeing less ability to raise prices on their diabetes drugs and more competition,” she said. “Alirocumab would be a great growth driver for their branded-drug division.”