Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Approves Updated
Acthar® Gel (Repository Corticotropin Injection) Label
DUBLIN – March 22, 2021 – Mallinckrodt plc, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved several updates to the full Prescribing Information (PI) for Acthar® Gel (repository corticotropin injection).
The new PI can be accessed here.
The label was updated after the FDA was provided safety monitoring and reporting data spanning more than 60 years. In addition to modernizing the prescribing information, the statement "Common adverse reactions for Acthar Gel are similar to those of corticosteroids" was removed in the prescribing information highlights section of the label; however the warnings and precautions section, which notes potential steroidogenic effects remains largely unchanged. These important updates provide up-to-date safety information available based on a sizable accumulation of pharmacovigilance reporting and clinical trial data, including phase IV clinical studies. The PI was updated in 2019 to characterize Acthar Gel as a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.
“We are pleased that the FDA approved these important updates to the Acthar Gel prescribing information to accurately reflect decades of research and clinical experience,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We remain committed to the continued modernization of Acthar Gel, a pharmaceutical product that helps healthcare providers take a multi-targeted approach across multiple indications and patient types, specifically in difficult-to-treat diseases and those patients with recurring and high disease activity."
Since acquiring Acthar Gel in 2014, Mallinckrodt has made a significant investment into the drug. For example, the company built on the existing data through further studies that evaluated the safety and efficacy of Acthar within our indications. Mallinckrodt initiated eight studies targeting combined enrollment of nearly 900 patients, including five randomized controlled clinical trials. In addition, the company has modernized manufacturing, further characterized the mechanism of action and expanded medical affairs and research activities.
Acthar® Gel is indicated for:
IMPORTANT SAFETY INFORMATION
Acthar is contraindicated:
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information for additional Important Safety Information.
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment’s 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. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use. 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; 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.
Green Room Communications
Daniel J. Speciale
Vice President, Finance and Investor Relations Officer
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