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Gene Therapies Make A Mark In US FDA Expedited Review Programs

 
• By Bridget Silverman

More than 20 gene therapies are being developed with increased interaction under FDA’s breakthrough and regenerative medicine programs. 

Researcher working with DNA on blurred background.

As the US FDA’s Center for Biologics Evaluation and Research braces for the coming wave of gene therapies, the agency has deemed at least 21 gene therapy products as breakthrough therapies or regenerative medicine advanced therapies, which offer valuable interactions with FDA during development to some of the most promising candidates.

To date, FDA has only approved three products using gene therapy – which the agency describes as “a technique that modifies a person’s genes to treat or cure disease” – for a total of four indications. One more is currently under review

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