The US Food and Drug Administration breakthrough therapy designation program has granted a dozen new BTDs in 2021, including designations for seven novel agents.
Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021
With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.