Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Tenapanor could be an option for dialysis patients who cannot tolerate phosphate binder therapy or who need more help in reaching their serum phosphorous targets, advisory committee members said; Office of New Drugs director Peter Stein is expected to rule on Ardelyx’s appeal of a complete response letter within 30 days.
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
Based on promising Phase II data, two companies in South Korea are moving ahead with late-stage development in the gout space, with JW Pharmaceutical getting approvals to begin a multinational Phase III trial for epaminurad, while LG Chem has recently submitted an application for a Phase III program with its contender tigulixostat.