US FDA’s Help May Get Charleston’s Hydexor Through Second Advisory Committee
After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.
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US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
But CDC seems more skeptical, postponing discussion during the ACIP meeting and aiming to talk to FDA about the issue ‘in the appropriate timeline.’
Discussion also reopened the debate on allowing universal boosting with mRNA vaccines, with advisors giving FDA more leeway to allow some younger Americans to get an additional mRNA shot regardless of their occupation or underlying health conditions.