FDA Panel Votes Against Q-Med's Knee Injection Product
August 19 2009 - 4:12PM
Dow Jones News
A panel of medical experts recommended Wednesday that federal
regulators not approve Q-Med AB's (QMED.SK) knee-injection product,
Durolane.
The panel voted 6-to-1 to recommend against approval for the
product, saying studies submitted by the company didn't show it was
effective enough when compared to a placebo. The U.S. Food and Drug
Administration doesn't have to follow its panel's advice, but
generally does.
Durolane is already sold in Europe. It's a gel that's injected
into the knee to help increase joint lubrication and cushioning and
relieve pain. It's used to relieve pain in patients with
oestoarthritis of the knee who haven't responded to other pain
treatments.
If approved, the product will be marketed by Smith & Nephew
Plc (SNN).
Mark Melkerson, director of the FDA's division of orthopedic,
surgical and restorative devices, said the panel "couldn't get past
the fact" that two studies submitted by the company showed it
wasn't more effective when compared to a placebo.
Melkerson said the panel was also concerned that a third study
showed the product was only marginally better than a competitor's
product.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com