Akcea Waylivra's Surrogate Endpoint Gains Support At US FDA Advisory Committee
In wide-ranging meeting, majority of panelists believe volanesorsen's surrogate marker will correlate to clinical outcomes such as reduced pancreatitis.
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US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.
In first half of 2018, CRLs were rarely issued for CDER-regulated novel agents, but FDA's rejection of Waylivra marks second in two weeks.