Go read all about the to and fro at the committee, over at MedScape online -- but here's an interesting bit:
. . . .The FDA accepted the biologic license application (BLA) for Ragwitek in May 2013. Merck's BLA included data from 5 clinical studies in adults aged up to 85 years. The committee vote was partially split, however, because the 2 phase 3 efficacy studies involved only persons aged up to 50 years, and not people aged 50 to 65 years, for which approval has been requested. . . .
With 9 members of the advisory committee voting, 6 voted yes that the data provided evidence of efficacy, 2 voted no, and 1 abstained. Those 3 members, however, agreed that if the language of the question they were asked to vote on had been restricted to people aged up to 50 years, they would have voted yes. . . .
So -- in about six weeks, it ought to get a final full FDA green light. The likely only open question -- at this point -- is whether the full FDA will aprove it through age 65 -- or just through age 50 (for which there are solid data points).
2 comments:
"The biologic candidate is not likely to crack the $500 million a year mark (a half blockbuster), in my opinion..."
Still, 'nothing to sneeze at.'
C'mon, I thought you would've used it before I did!
Heh!
Excellent!
Namaste!
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