FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder
Summary
] The FDA has rejected an experimental regenerative therapy that Enzyvant developed to restore immune system function in babies born with a rare disorder. Enzyvant received the notification, formally known as a complete response letter, on Wednesday, CEO Rachelle Jacques tells Xconomy. Jacques says the issues raised by the agency focus on how the therapy is made and there were no questions about the therapy’s safety or efficacy, nor is Enzyvant being asked to conduct additional clinical testing. Jacques adds that the FDA rejection does not affect the company’s plans to pursue approval in Europe, or to develop the therapy for other T cell disorders. In the nearer term, Jacques says Enzyvant plans to work with Duke to figure out a way to ensure that patients who have congenital athymia can continue to receive the treatment.
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