STAINES-UPON-THAMES, United Kingdom, Aug. 22, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, confirmed today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for stannsoporfin.
In the letter, the Agency provided guidance regarding areas of further evaluation for resubmitting the stannsoporfin NDA for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice, or hyperbilirubinemia.
"The letter from the FDA was not unexpected following the outcome at the recent Advisory Committee meeting," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer. "We are evaluating the Agency's guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward."
Until that discussion, Mallinckrodt does not expect to make a decision related to future efforts or investment in the developmental product.
Stannsoporfin is a heme oxygenase inhibitor under investigation for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice, or hyperbilirubinemia. If approved, stannsoporfin would be a first-in-class pharmacologic treatment for severe jaundice in newborns with a novel mechanism of action that inhibits bilirubin production at its source.1 The safety and effectiveness of stannsoporfin have not yet been established by the FDA.
ABOUT NEONATAL JAUNDICE
Neonatal, or newborn, jaundice is a condition caused by the build-up of bilirubin, a yellow substance in the blood that is formed as red blood cells break down as part of the body's natural process.2 About three in five babies (60 percent) have jaundice at birth, and most often it goes away without treatment.2 However, in some cases, the newborn is not able to clear excessive levels of bilirubin resulting in an imbalance that leads to a condition called hyperbilirubinemia.2,3 If severe and left untreated, this condition may lead to neurologic complications, including irreversible brain damage.3 The current standard of care for treating severe jaundice is phototherapy, which targets the excess bilirubin that has accumulated in the baby's bloodstream and helps the body to control the bilirubin.4 However, it does not address bilirubin production.3
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; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
The forward-looking statements in this release concerning stannsoporfin including expectations with regard to future research plans and potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; future commercialization efforts; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
Senior Communications Manager
Chief Public Affairs Officer
1 InfaCare Pharmaceutical Announces the Successful Completion of its Phase IIB Multicenter development program for Stannsoporfin [press release]. Trevose, PA: InfaCare Pharmaceutical Corporation. March 24, 2016. https://www.prnewswire.com/news-releases/infacare-pharmaceutical-announces-the-successful-completion-of-its-phase-iib-multicenter-development-program-for-stannsoporfin-300241169.html. Accessed March 20, 2018.
2 Newborn Jaundice. March of Dimes Web site. https://www.marchofdimes.org/baby/newborn-jaundice.aspx. Updated April 2013. Accessed March 20, 2018.
3 Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics.1999;103 :6– 14.
4 Muchowski KE. Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam Physician. 2014;Jun 1;89(11):873-878.
SOURCE Mallinckrodt plc