U.S. regulators said that companies developing drug-coated stents, designed to prop open clogged arteries, should undertake new testing to identify the medicines used and show how the drugs break up in the body.
FDA wants more-detailed studies from drug-coated-stent makers
By CATHERINE LARKIN
The tests need to be done before trials in humans start, the U.S. Food and Drug Administration (FDA) said Wednesday in a draft guidance on the agency's website. The agency also recommended longer human studies, larger safety databases and continuing studies of patients after devices reach the market.
Sales of Boston Scientific Corporation's Taxus stent, made in Maple Grove and Ireland, and Johnson & Johnson's Cypher -- the first drug-coated stents in the U.S. -- plunged about 30 percent in 2007, after studies said long-term use may lead to life-threatening blood clots. In approving Fridley-based Medtronic Incorporated's Endeavor in February, the FDA asked for at least a five-year study about clotting risks. Analysts expect similar conditions for Abbott Laboratories' Xience, set to be approved this year.
"The downside to the draft guidelines is that it will cost companies more money to satisfy the FDA regulations, and will take more time to gain marketing clearance," said Lawrence Keusch, an analyst at Goldman Sachs in Boston, in a note to clients Wednesday. "On the other hand, for those companies that are currently on the U.S. market [or are about to gain FDA clearance, as is the case with Abbott], the revised guidelines are likely to keep new competitors out of the market until 2012."
Stents are tiny wire-mesh tubes used to keep arteries open after they've been cleared of fatty clogs. Newer stents are coated with medicines to prevent scar tissue from growing inside the device and reblocking the artery, a main complication of older, bare-metal versions.
about the writer
CATHERINE LARKIN
The tradition of MSP’s dominant carrier sharing year-end profits with employees on Valentine’s Day dates back to 2007.