FDA unveiling faster method for approving gene-editing therapy

Genetic engineering, GMO and Gene manipulation concept. Hand is inserting sequence of DNA. 3D illustration of DNA.

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(NewsNation) — The U.S. Food and Drug Administration plans to unveil a quicker approach to approving custom gene-editing treatments.

According to Bloomberg News, Vinay Prasad, who oversees gene therapies at the FDA, said the plans will be published in early November. He foresees the approach sparking curiosity for the next wave of doctors to develop treatments for conditions that only concern a small number of people.

“Regulation has to evolve as fast as science evolves,” Prasad said. “The agency is going to be extremely flexible and work very fast with the scientists who want to bring these therapies to kids who need it.”

“The moment we publish our paper, the investment in this space will flow. It will turn the spigot on.”

As a result of the news, the shares of CRISPR Therapeutics, Editas Medicine Inc. and Intellia Therapeutics Inc. all increased. CRISP Therapeutics’ arrival has allowed scientists to potentially develop cures for many of the 7,000 rare diseases in the world.

The FDA is also allowing combined trials of patients linked with genetic disorders.

“It allows for the amazing ability to tackle multiple genetic diseases at once,” said Rebecca Ahrens-Nicklas, physician at the Children’s Hospital of Philadelphia.

“It’s important to highlight how quickly things are changing. The FDA today is not the same FDA that existed six months ago.”

Earlier this year, 10-month-old KJ Muldoon became the first person in history to have his genes custom-edited to cure an inherited disease.





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