The panel was not convinced about the drug's effectiveness in patients with end-stage renal disease (or "ESRD") who are already receiving dialysis -- with only six of 16 voting to introduce such ESRD patients to Vytorin®. So, only kidney patients not yet on dialysis have been suggested as Vytorin candidates -- per Bloomberg tonight:
. . . .The panel voted 16-0 during a meeting today in Silver Spring, Maryland, that the Food and Drug Administration should approve Vytorin to treat patients with kidney disease who aren’t on dialysis. The advisers also decided 10-6 that the drug shouldn’t be allowed for patients with end-stage renal disease on dialysis treatment. The agency doesn’t have to follow the panel’s advice. . . .
Merck gained less than 1 percent to $34.19 at the close in New York. The shares have declined 5.1 percent this year. . . .
Even if the full FDA follows the panel's recommendation, here is the case against any expanded approval, from a friend of the blog: SHARP didn't establish that the Zetia® portion did anything beneficial -- it could all be due to the simvastatin in the Vytorin combo-pill. So, why approve?
Net, net, today's panel is at best modestly good news, as the Merck NYSE price action suggested. This is not likely to move the Merck needle much, given that many such patients are already on statins -- a generally-much-cheaper alternative -- which has years and years of efficacy/outcomes data.
3 comments:
"SHARP didn't establish that the Zetia® portion did anything beneficial -- it could all be due to the simvastatin in the Vytorin combo-pill. So, why approve?"
Up until a few years ago it was a legal requirement for approval of combination drug products that you had to show that each product contributed to the effect. This requirement is no longer in the CFR (this occurred during the last administration). I don't know how or why it was removed but it may have something to do with FDA's push that began under the last adminstration and that is continuing to be more industry friendly and assist with drug development and approvals.
Salmon
Exactly, Salmon!
Thanks -- seems this is one rule that should not have been liberalized.
Namaste
Prehaps this is one of the approvals that FDA Commissioner was referring to in the following statement from the NYTimes last week.
"Now that approvals are increasing, however, Dr. Hamburg is claiming some credit by saying that the agency has lowered some approval standards."
http://www.nytimes.com/2011/11/04/health/policy/drug-approvals-rise-for-fda.html
Salmon
Post a Comment