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.
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.
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
The agency isn't required to follow the advice of its advisory panels, but it usually does.
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.
New updates will be posted. Watch for the transcripts of the meeting.