Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews
In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.
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As Sarepta again brings a product application from the brink of rejection to the cusp of approval, the one-month review delay creates more assurance the confirmatory EMBARK trial will be completed as well as providing more time for label negotiations with the US FDA.
The EMBARK trial’s availability to more patients likely contributed to the much quicker enrollment than confirmatory trials for Exondys 51, Vyondys 53 and Amondys 45, which also saw enrollment targets and eligibility ages change over the years.
The Duchenne muscular dystrophy candidate should be approved because it will help grow development in the space, patient groups argue, not just because of the value the gene therapy could provide to those receiving the treatment itself.