Sarep­ta crit­ic Jenk­ins is ex­it­ing the FDA, and Wood­cock takes di­rect charge of the OND af­ter a painful rup­ture

A few weeks ago, John Jenk­ins, the long­time di­rec­tor of the FDA’s Of­fice of New Drugs, caused quite a stir with some ad­vice for biotechs to avoid the same reg­u­la­to­ry path­way adopt­ed by Sarep­ta, the new win­ner of a con­tro­ver­sial FDA ap­proval for Ex­ondys 51 for Duchenne mus­cu­lar dy­s­tro­phy.

“Path tak­en by Sarep­ta NOT a good mod­el for oth­er de­vel­op­ment pro­grams,” de­clared one of Jenk­ins’ talk­ing points un­der a fi­nal sec­tion marked “lessons learned” from eteplirsen and oth­er cas­es.

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