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VA Drops Roche’s Avastin for Eye Disease on Infection
Sept 26, 2011
The Department of Veterans Affairs, a provider of health care to more
than 5 million people, said it will cease using Roche AG’s Avastin to
treat an eye disease as it investigates reports of serious infections
and blindness.
Regeneron Pharmaceuticals Inc. (REGN), the developer of a rival drug for
the condition known as wet age-related macular degeneration, rose
$10.21, or 16 percent, to $74.56 at 2:16 p.m. in Nasdaq Stock Market
trading in reaction.
Avastin is only approved in the U.S. to treat certain cancers. Once a
drug is cleared, though, it can be prescribed by doctors for any
ailment. Lawmakers have been pressuring U.S. health programs such as
Medicare to expand Avastin’s use for the potential savings. Avastin
costs about $50 a dose compared with $2,000 for Lucentis, a rival
treatment that is approved for the eye disorder.
The medicine, with $6.4 billion in 2010 sales, works in both cancer and
the eye disease by preventing blood-vessel growth. The VA decision,
announced in an e-mail to Bloomberg News, comes after Food and Drug
Administration advisers rejected the drug’s use in breast cancer because
of the risk of deadly bleeding. The VA decision may chill future calls
to expand Avastin’s uses, said Scott Gottlieb, a former deputy
commissioner for medical and scientific affairs at the FDA.
“I don’t think doctors are getting their cues from the VA, but I think
you’ll see implications on the policy side,” Gottlieb, who consults for
Genentech, the unit of Basel, Switzerland-based Roche that developed the
drug. “I think you’ll see proponents less likely to stand up for it.”
VA Investigation
The VA is investigating eye infections at facilities around the country
and is no longer using Avastin, the department said in an e-mailed
statement.
“Once the investigation is complete, VA will reassess how Avastin and
similar therapies may be made available for ophthalmologic use and will
issue further guidance,” the statement said.
The FDA last month linked at least a dozen serious eye infections in the
Miami area to repackaged Avastin. Some of the cases resulted in
blindness.
Roche is aware of reports of patients in Miami, Nashville and Los
Angeles who have developed severe eye infections, some resulting in
permanent vision loss, after receiving Avastin, Terence Hurley, a
spokesman for the company, said. In Miami, the syringes were
contaminated with bacteria and the FDA found no evidence of
contamination in vials of Avastin, Hurley said.
To contact the reporter on this story: Anna Edney in Washington at
aedney@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at |