Mallinckrodt (MNK) to Present New Retrospective Data on Effect of Acthar Gel

Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that an abstract highlighting results from a retrospective analysis evaluating the corticosteroid-sparing effect and reduction of corticosteroid burden of Acthar® Gel (repository corticotropin injection) therapy in patients with advanced sarcoidosis ,1 has been selected for a poster presentation at the Academy of Managed Care Pharmacy (AMCP) 2023 Annual Meeting taking place in San Antonio, Texas from March 21-24, 2023.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the US Food and Drug Administration (FDA) for the treatment of symptomatic sarcoidosis and is only commercially available in the US2 Acthar Gel is also referenced in the European Respiratory Society (ERS) treatment guidelines—which list Acthar Gel among the various anti-inflammatory treatments for pulmonary sarcoidosis and note it can be used on a case-by-case basis when other therapies are ineffective or not tolerated—and a US expert panel provided consensus recommendations on the use of repository corticotropin injection for the treatment of pulmonary sarcoidosis.3,4

Please see Important Safety Information for Acthar Gel below.

The retrospective analysis used data from a large administrative pharmacy and medical claims database (Symphony Health Solutions), including a total of 1,361 sarcoidosis patients (n=735 for Acthar Gel cohort; n=626 for alternative fourth-line cohort) from 2014-2020 . Outcomes were compared as change from baseline and Acthar Gel adherence was determined by proportion of days covered in the follow-up period. The analysis found that, after treatment with Acthar Gel, patients had greater reduction from baseline in any corticosteroid fills (-9.0% vs. -3.2%) and extended use corticosteroid fills (-10.0% vs. -3.0%) compared to those receiving fourth-line treatment, with Acthar Gel above average adherence showing greater reduction than below-average adherence in both measures (-11.2% vs. -6.1%; -11.6% vs. -7.6% respectively).1

George J. Wan, Ph.D., MPH, Vice President Health Economics and Outcomes Research at Mallinckrodtsaid, “We’re excited to share these data that not only provide valuable insight into the association between use of Acthar Gel and reduction in corticosteroid use, but also reinforce the importance of treatment adherence to help improve outcomes for patients with advanced sarcoidosis. 1 We remain committed to addressing the unmet needs of critically ill patient populations and are proud to continue the collection of real-world data to help inform patients’ treatment options.”

In this retrospective analysis, patients treated with Acthar Gel also had significantly greater reduction of extended corticosteroid use at all dose levels compared to fourth-line treatment, with Acthar Gel above average adherence reduction better than below average (-9.5% vs. -5.7% for medium corticosteroid dose; -10.0% vs. -8.6% for high corticosteroid dose, respectively).1

Data collected in a retrospective analysis may have errors or omissions. Outcomes may be influenced by therapies not evaluated in the study and the clinical outcomes may not be solely attributable to Acthar.

This study was funded by Mallinckrodt Pharmaceuticals. Presentation details are as follows:

Presentation TitleCorticosteroid use and adherence in patients treated with Acthar Gel for advanced sarcoidosis.PresenterKyle Hayes, MSPresentation Date: Thursday, March 23, 2023, at 11:30am – 1:00pm CT / 12:30pm – 2:00pm ETLocation: Henry B. Gonzalez Convention Center, Hall 2

Additional information is available on the Academy of Managed Care Pharmacy (AMCP) 2023 Annual Meeting website.

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