Both Drugs Have Been Recommended By The FDA Advisory Panel For The Treatment Of Hepatitis C.
Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.
April 28 The FDA advisory panel unanimously backed the approval of Vertex Pharmaceuticals proposed hepatitis C-drug telaprevir.
April 27 - VICTRELIS (boceprevir) was unanimously recommended for approval by the FDA Advisory Committee .
Merck & Co. expects to launch boceprevir in May, pending U.S. regulatory approval
The FDA is not required to follow the panel's recommendation, though it usually does. The FDA will make the final approval decision which is expected by May 23.
1-The cure rate for new patients taking telaprevir ranged between 75 and 79 percent, compared with 60 and 65 percent for boceprevir.
2-Most panelists said that patients who had previously failed treatment could likely achieve a cure within six months — half the time needed with older drugs — when taking telaprevir
3-As for Merck's drug Boceprevir those same patients would likely need a full year's worth of treatment with triple therapy. 4-Vertex executives said they were exploring a twice-daily regimen of telaprevir.
5-The agency said the risks of telaprevir were associated with skin reactions, such as rash, and anemia. The main safety concern discussed by the panel was severe rashes in a small number of patients, including three suspected cases of Stevens-Johnson Syndrome, a life-threatening outbreak of blisters. Vertex said the rashes disappeared when telaprevir was stopped.
Panelists urged Vertex to warn about the problem and tell doctors and patients how to spot a serious rash and when to stop treatment if needed.
Vertex offered rashes were managed in most patients with antihistamines and topical corticosteriods
1-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.
2-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.
3-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.
4-Members of the FDA panel appeared to support shorter treatment for patients who show early responses to boceprevir.
5-Boceprevir's main risk is blood disorders such as anemia, a lack of red blood cells that causes fatigue and other symptoms, FDA reviewers said. Panelists said the problems needed monitoring but were manageable and usually not severe.
6-Some voiced concern that patients would find it challenging to stick with the three-times-a-day dosing for boceprevir on top of the two older medicines. (PEG-IFN plus RBV)
To read the article in its entirety, please visit HCV New Drug Research
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