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Agreement reached with FDA on submission of additional non-clinical information for NDA review of lumateperone for the treatment of schizophrenia
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Lumateperone PDUFA goal date extended three months to December 27, 2019
Conference call scheduled today at 8:30 am ET
NEW YORK, Aug. 05, 2019 (GLOBE NEWSWIRE) – Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that it recently met with the U.S. Food and Drug Administration (FDA) and reached agreement to submit additional non-clinical information in connection with the FDA’s ongoing review of the Company’s New Drug application (NDA) for lumateperone for the treatment of schizophrenia. The FDA has informed the Company that the planned submission of this additional information constitutes a major amendment to the NDA, resulting in a three-month extension of the Prescription Drug User Fee Act (PDUFA) goal date to December 27, 2019 in order to provide time for a full review of the submission.
“We are pleased with the productive dialogue we have had with the FDA,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We intend to provide the FDA with the requested information in the coming weeks and we believe this information will be sufficient to address the FDA’s requests.”
The Company has agreed with the FDA to provide additional information related to toxicology findings in previous animal studies with the objective to further substantiate the Company’s position that those findings are not relevant to humans due to species specific differences in the metabolism of lumateperone. The Company is performing a limited number of in-vitro analyses, including the analysis of animal and human plasma samples from previous studies to confirm that the metabolic pathway, and the metabolites formed, are different in animals and humans. The Company has commenced the requested analyses and expects to complete them shortly and provide the information to the FDA.