Gene therapy deaths push back Astellas-Audentes' approval by at least two years
The three deaths in an Astellas gene therapy trial last year will push back the experimental therapy’s approval by “more than two years” as Astellas plans a second study, the company told Endpoints News in an email Tuesday. That means a regulatory application would not come until at least mid-2022.
When Astellas bought out the gene therapy biotech Audentes for $3 billion in December 2019, the Japanese pharma believed they could file for approval for their lead candidate in the US in mid-2020 and in Europe in the latter half of 2020. The therapy was a one-time treatment for a rare and deadly muscle-wasting disorder X-linked myotubular myopathy, or XLMTM, and executives believed the 26-person study would be enough to secure approval.
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