FDA Backs Anti-Nausea Drug for Some
Posted on: Thursday, 6 March 2003, 06:00 CST
FDA Backs Anti-Nausea Drug for Some
source: Associated Press Health News
WASHINGTON - Merck & Co.'s experimental treatment for preventing nausea and vomiting in chemotherapy patients won key support Thursday from a group of government advisers, meaning the drug will likely be approved for sale in the United States.
The group of outside experts told the Food and Drug Administration that Merck's Emend cut down vomiting and nauseous episodes better than standard available treatments.
Vomiting and nausea often plague patients on certain chemotherapies called highly emetogenic because they are known to be difficult to stomach.
FDA, which rarely goes against the advice of its expert panels, is expected to meet with the Whitehouse Station, N.J.-based company to work out final approval details.
Panelists all voted in support of Emend's safety and effectiveness, but voted against approving it for a broad range of chemotherapies.
Instead, the group said the drug should be approved for use with the chemotherapies most represented in Merck's studies: GlaxoSmithKline PLC's Navelbine, as well as Taxol, Platinol and Etopophos from Bristol-Myers Squibb Co.
Although the panel recommended that limit, doctors are free to prescribe approved drugs for any use.
Emend works by focusing on the back of the brain, instead of the gut. The oral treatment is given for three days in combination with a standard regimen of commonly prescribed anti-vomiting drugs.
Merck is asking for the drug's approval for both nausea and vomiting prevention immediately after chemotherapy and up to five days after chemotherapy.
If approved, it will be the first in a new class of drugs and the only treatment available for treating vomiting a few days after chemotherapy.
Merck shares closed Thursday at $51.95, up 8 cents, on the New York Stock Exchange.
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