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Eteplirsen Review Timeline: CDER Director Was Involved Early And Often

 
• By Sue Sutter

Review documents show eight center director briefings during the IND phase and seven after NDA submission of Sarepta's DMD drug.

FDA review documents released in connection with the accelerated approval of Sarepta Therapeutics Inc.'s Exondys 51 (eteplirsen) describe Center for Drug Evaluation and Research Director Janet Woodcock's involvement with review activities during the IND and NDA stages of the Duchenne muscular dystrophy drug.

In his appeal to the Scientific Dispute Process Review Board, Office of Drug Evaluation I Director Ellis Unger lists a total of 15 center director briefings associated with eteplirsen's development, more than half of which occurred prior to NDA submission

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

More from Product Reviews

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PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
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