STAINES-UPON-THAMES, United Kingdom, Jan. 4, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced it has successfully completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek approval of its recently acquired developmental product stannsoporfin. If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.
"We are pleased to complete this important milestone for stannsoporfin," said Steve Romano, M.D., Chief Scientific Officer and Executive Vice President of Mallinckrodt. "This brings us one step closer to addressing an unmet need for therapies to treat thousands of infants at risk for severe jaundice, and we look forward to working closely with the FDA toward the goal of obtaining approval of stannsoporfin to treat this population."
ABOUT SEVERE HYPERBILIRUBINEMIA AND STANNSOPORFIN
In the U.S., the total number of term births is estimated at 3.97 million per year1,2 and, of those, approximately 750,0003 infants are treated for jaundice. Of those treated, some may be unresponsive to phototherapy – the current standard of care – even with extended and repeated courses of the treatment4, and patients face the risk of developing severe jaundice prior to discharge. A small percentage of full-term infants may experience elevated bilirubin levels after discharge and be at risk of severe jaundice5, requiring hospital readmission. The combined potential patient treatments required annually in the U.S. for severe jaundice is approximately 70,000 to 125,000.
Stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin. The safety and effectiveness of stannsoporfin have not yet been established by FDA. If approved, stannsoporfin is expected to be used for late-preterm and full-term infants at risk of developing complications associated with severe jaundice.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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3 HCUP (Healthcare Cost and Utilization Project) KID Data
4 Mallinckrodt market research/management projections
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SOURCE Mallinckrodt plc