Updated August 31, 2021
Our mission at Mallinckrodt is Managing Complexity. Improving Lives. Our employees live this mission every day, and we're focused on providing safe, effective treatments that make a difference in the lives of underserved patients, especially those with severe and critical conditions.
Mallinckrodt is committed to supporting patients and healthcare providers. We have a dedicated team ready to help patients and healthcare providers work through the Acthar Gel approval process, assist patients with advocating for themselves as well as provide support throughout treatment. Watch the video below to hear Bianca’s story and how our patient support services assisted her.
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides that is indicated in multiple therapeutic areas including rheumatology, ophthalmology, nephrology, pulmonology and neurology.1
Acthar Gel is FDA-Approved for 19 Indications
Acthar Gel has an established efficacy and safety profile as well as a long track record of clinical evidence that spans nearly 70 years. In addition, Acthar Gel has 19 indications, including infantile spasms which was approved in 2010.1 Please see Indications and Important Safety Information for Acthar Gel below.
Acthar Gel is often prescribed by doctors predominately as a later-line treatment to a small subset of patients suffering from various, sometimes devastating, diseases and may be the last treatment option for those who need an alternative therapy.
Acthar Gel’s label was updated in February 2021 after the FDA was provided with 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 (PI) 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 based on a sizable accumulation of pharmacovigilance reporting and clinical trial data, including phase IV clinical studies. The PI was previously updated in 2019 to characterize Acthar Gel as a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.1
Mallinckrodt’s Investment in Acthar Gel
Since acquiring Acthar Gel in 2014, Mallinckrodt has made, and continues to make, a significant investment in the drug. For example, the company built on existing data through further studies that evaluated the safety and efficacy of Acthar Gel within our indications. Mallinckrodt initiated eight studies targeting combined enrollment of nearly 900 patients, including five randomized controlled clinical trials.2 The company has modernized manufacturing, further characterized the mechanism of action and expanded medical affairs and research activities. In addition, Mallinckrodt has a dedicated team prioritizing access and providing support.
Significant Clinical Evidence Supports the Efficacy of Acthar Gel
On April 15, 2020, Mallinckrodt announced the publication of findings from its randomized, placebo-controlled, double-blind Phase 4 study to assess the safety and efficacy of Acthar in patients with persistently active rheumatoid arthritis (RA) despite treatment with stable background disease-modifying antirheumatic drugs (DMARDs) and low-dose glucocorticoids.3 Results of the study were published in Rheumatology and Therapy, an open access peer-reviewed journal.
Two randomized clinical trial were submitted in support of FDA approval of Acthar Gel’s effectiveness as a treatment for Infantile Spasms (IS)1, one of which compared Acthar Gel to prednisone. In this pivotal trial, 13 of 15 (86.7%) patients had a positive response to Acthar Gel vs. 4 of 14 (28.6%) that responded to prednisone (p<0.002). Patients who responded in the study treated with a two-week course of Acthar Gel therapy experienced complete suppression of the two key measures of disease – spasms and hypsarrhythmia.1 Irritability and voracious appetite were the most frequent side effects, but no infant required stopping or modifying treatment.4 The IS clinical trial results appear in Section 14 of the full Prescribing Information1 for the drug.
Completed and Ongoing Clinical Studies
• Phase 4 trial in Pulmonary Sarcoidosis
• Phase 4 trial in Lupus
• Phase 4 trial in Rheumatoid Arthritis
• Phase 4 trial in Multiple Sclerosis
• Phase 4 trial in Uveitis
• Phase 4 study in Focal Segmental Glomerulosclerosis (Nephrotic Syndrome)
• Phase 4 study in Keratitis
• Observational study in the treatment of MS Relapse
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information for additional Important Safety Information which can found at Acthar.com.
1Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.
2Data on File--ref-04625
3Fleischmann, R, Furst, D.E., Connolly-Strong, E., Liu, J., Zhu, J, Brasington, R. Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial, Rheumatology Therapy, https://link.springer.com/article/10.1007/s40744-020-00199-3
4Baram, T.Z., Mitchell, W.G., Tournay, A., Snead, O.C., Hanson, R.A., Horton, E.J., High-dose Corticotropin (ACTH) Versus Prednisone for Infantile Spasms: A Prospective, Randomized, Blinded Study. Pediatrics, 1996; 97 (3) 375-379