Translate Bio announced that the company has received verbal notification from the FDA that the agency has completed its review of the company’s investigational new drug application, or IND, submission for MRT5201 for the treatment of ornithine transcarbamylase, or OTC, deficiency and has additional clinical and nonclinical questions. The company submitted the IND in December 2018 to support the initiation of a Phase 1/2 clinical trial in patients with OTC deficiency. The FDA is placing the IND on clinical hold until these questions are resolved. The company expects to receive formal written communication with additional information from the FDA in the near future and plans to work with the FDA in an effort to resolve its questions as promptly as possible.
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