Novartis to Seek Approval by Year’s End to Test Gene Therapy Candidate

Novartis to Seek Approval by Year’s End to Test Gene Therapy Candidate

286357

Novartis to Seek Approval by Year’s End to Test Gene Therapy Candidate

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…

You must be logged in to read/download the full post.