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BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission of New Drug Application with the U.S. FDA for BBP-870 for the Treatment of MoCD Type A
BOSTON, Dec. 03, 2019 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug
About this update from Bridgebio Pharma, Inc.
[{"type":"text","content":"BOSTON, Dec. 03, 2019 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.\n Currently, there are no approved therapies that alter the course of MoCD Type A, which results in severe and irreversible neurological injury. Fosdenopterin, an investigative cPMP substrate replacement therapy, aims to reduce buildup of toxic sulfites and alleviate central nervous system symptoms in infants and children with MoCD Type A. “Initiation of our rolling NDA submission is a significant milestone for our company and an important step in providing a therapy to patients and their families living with MoCD Type A,” said Origin Biosciences CEO Neil Kirby, Ph.D. “We look forward to making fosdenopterin available to infants and children with this devastating disease as soon as possible as they currently have no treatment options that target the disease at its source.” “BridgeBio was founded to develop breakthrough medicines for patients with genetic diseases. As we begin our first rolling new drug application with the FDA, we are taking a significant step forward for patients by targeting MoCD Type A at its source through the provision of the monophosphate cPMP. We want to thank patients and their families, the scientists, and all others involved who helped us reach this critical moment,” BridgeBio CEO Neil Kumar, Ph.D., said. “Our growing company has more than 15 drug discovery and development programs. We hope Origin’s NDA will be the first of many we submit to the FDA in our pursuit of life-changing therapies for patients, including an anticipated submission in 2020 from BridgeBio subsidiary QED Therapeutics for infigratinib for second line treatment of cholangiocarcinoma.” The regulatory submission will primarily be supported by data from two ongoing trials, a global Phase 2 clinical trial (NCT02629393) and a global Phase 2/3 clinical trial (NCT02047461). Under its rolling review process, the FDA can review components of a marketing application as they are submitted rather than requiring all components to be received prior to initiating review, potentially allowing for faste...