— Action date set for August 22, 2018 —
STAINES-UPON-THAMES, United Kingdom, Feb. 23, 2018 /PRNewswire/ —Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking 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.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set its action date to respond to the NDA as August 22, 2018. The agency previously granted its Fast Track status to stannsoporfin. The Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need1.
"We are pleased the FDA has accepted our application," said Steve Romano, M.D., Chief Scientific Officer and Executive Vice President of Mallinckrodt. "We look forward to working with the agency in the coming months on the potential approval of stannsoporfin as a new treatment option for thousands of infants at risk for developing severe jaundice who have an unmet medical need."
1 https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
ABOUT SEVERE HYPERBILIRUBINEMIA AND STANNSOPORFIN
Neonatal jaundice is a common condition in neonates that is associated with the yellowing of the skin and the whites of the eyes, typically in the first few days after birth. In most cases, it does not require treatment; however, elevated bilirubin levels in the blood (hyperbilirubinemia) can be toxic and may potentially lead to neurologic complications, including encephalopathy or irreversible brain damage. Currently, phototherapy is used to help the body clear bilirubin and bring levels down.
Stannsoporfin is a heme oxygenase inhibitor under investigation for its potential to reduce the production of bilirubin in infants at risk for severe neonatal jaundice. The safety and effectiveness of stannsoporfin have not yet been established by the FDA.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning stannsoporfin including expectations with regard to future regulatory actions 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 Mallinckrodtdoes 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.
CONTACTS
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
