Feb 13, 2021

Novartis to Seek Approval

Posted by in category: biotech/medical

Novartis Gene Therapies is planning to submit an investigational new drug application (IND) for OAV201, its Rett syndrome gene therapy candidate, by the end of the year, the company announced in a letter to the Rett community.

If the IND is approved by the U.S. Food and Drug Administration (FDA), Novartis would be allowed to begin clinical trials to test the therapy in people with Rett syndrome.

“We recognize the significant unmet need among patients with Rett syndrome and want to again assure the Rett community that we are fully committed to pursuing a gene therapy for Rett syndrome, and that we are continuing our work with a sense of urgency and purpose,” the OAV201 development team at Novartis wrote in the letter, shared on the Rett Syndrome Research Trust’s website.

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