Regenxbio’s gene therapy latest example of FDA’s reversion to the mean

Regenxbio's announcement that it has “aligned with FDA” on a pathway toward accelerated approval of Navsunli clemidsogene lanparvovec for MPS II is the latest example of FDA putting products derailed under the leadership of Commissioner Marty Makary, CBER Director Vinay Prasad, and acting CDER Director Tracy Beth Høeg back on track.

Manufacturers of at least 11 products have now announced either approvals following complete response letters issued under the former leaders, or reversals of agency decisions that had made continued development difficult or impossible. The emerging pattern suggests that many of the regulatory obstacles erected during that period are proving less durable than they appeared at the time...