www.fdanews.com/articles/150393-pharma-blog-watch
Pharma Blog Watch
October 22, 2012
Safe Use Is the New Norm (DrugWonks Blog)
“Milton Friedman once said that the FDA was obsessed with safety. Some view that as a badge of honor, others not so much,” blogger Peter Pitts writes. Two recent FDA advisory committee votes should please both groups.
“Milton Friedman once said that the FDA was obsessed with safety. Some view that as a badge of honor, others not so much,” blogger Peter Pitts writes. Two recent FDA advisory committee votes should please both groups.
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A panel voted 9–6 to recommend approval for Genzyme’s mipomersen for homozygous familial hypercholesterolemia; and
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A second recent adcomm voted 13-2 in favor of approval for Aegerion’s lomitapide for homozygous familial hypercholesterolemia.
Both passing votes came despite serious risks and with a “needs-focused” philosophy. The committee also recommended a REMS targeting off-label use for lomitapide. “Benefit/risk at its finest,” Pitts writes. “Safe use is the new normal.”