"Yes" FDA advisory panel recommends approval of boceprevir

  • Wednesday, April 27, 2011
  • Posted by HCV New Drugs
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 FDA advisory panel recommends approval of boceprevir

AP) WASHINGTON - Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.

A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck’s boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group’s recommendation, though it usually does. A final decision is expected mid-May.

On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
(Copyright 2011 by The Associated Press. All Rights Reserved.)

HCV New Drugs Quick Notes;
Mentioned by the panel is the concern for the complexity of prescribing the new Hepatitis C drug. The other concerns are safety, risk, and resistance variance.
Labeling; 
The panelists were split on using boceprevir in (null responder) patients. These patients were not included in Phase III  trials, therefore no data is available. Also raised was the concern over the labeling allowing for treatment in advanced liver damage; Grade 3 Stage 4 patients .
Longer treatment duration was discussed in the difficult to treat patients; African Americans, patients with liver damage and for those people who have failed prior standard therapy.

The FDA will make the final approval decision

From The WSJ

FDA Panel Backs Merck Hepatitis C Drug

By JENNIFER CORBETT DOOREN

WASHINGTON—A Food and Drug Administration panel backed the use of Merck & Co.'s hepatitis C drug boceprevir, calling the product a game-changing advance in the treatment of the disease.
The panel of outside medical experts voted yes by a margin of 18-0 on the question of whether the available data support approval of the product in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the FDA approve boceprevir, which Merck has proposed marketing under the brand name Victrelis.
The agency isn't required to follow the advice of its advisory panels, but it usually does.
Indeed, FDA staff members suggested the agency was leaning toward approving boceprevir and a similar product, telaprevir, from Vertex Pharmaceuticals Inc. Telaprevir will be reviewed Thursday by the same FDA panel... Continue Reading..

From The Boston Globe;

Panel recommends FDA approval of Merck drug
By Robert Weisman, Globe Staff

Silver Spring, Md. --- A scientific advisory panel today unanimously recommended that the Food and Drug Administration approve a Merck & Co. drug candidate for hepatitis C that is expected to compete with a rival drug from Vertex Pharmaceuticals Inc. of Cambridge.

The vote to recommend the approval of the Merck drug, called boceprevir, followed a day-long hearing in which physicians warned of possible side effects and concerns about what might happen if patients developed anti-viral resistance.

But panel members said the benefits of the drug outweighed those concerns.
Continue Reading....

New updates will be posted. Watch for the transcripts of the meeting.


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