Updated September 24, 2019
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.
Acthar Gel (repository corticotropin injection) is for many frequently, very sick patients, a life-changing drug. We are proud of Acthar Gel and the important investment we are making in it, and we are gratified that we can positively impact patients' lives through this drug.
Acthar Gel is FDA-Approved for 19 Indications
While Acthar Gel has been used to treat patients for more than 50 years, its label was reviewed by the FDA in 2010, at which time the FDA determined there was sufficient scientific and clinical evidence to support its use in the 19 various indications1 contained in the current Acthar Gel label.
One of these indications is for use of Acthar Gel in the treatment of Infantile Spasms (IS)2, for which it is considered the gold-standard for treatment. Two randomized clinical trials were submitted in support of FDA approval of the drug and its effectiveness as a treatment for IS, one of which compared Acthar Gel to prednisone. In that trial 86.7% of patients had a positive response to Acthar Gel vs. 28.6% that responded to prednisone. Patients who responded in the pivotal study treated with a two-week course of Acthar Gel therapy experienced complete suppression of the two key measures of disease – spasms and hypsarrhythmia. The IS clinical trial results appear in Section 14 of the full prescribing information for the drug.
Aside from treatment of IS, Acthar Gel is often prescribed by doctors predominantly as a later-line treatment to a small subset of patients suffering from various devastating diseases for whom other approved FDA treatment options have failed.
Mallinckrodt’s Investment in Acthar Gel
Since acquiring Acthar Gel in 2014, Mallinckrodt has invested more than $500 million into the drug, specifically: building on substantial clinical experience as well as previously completed and largely independent clinical case series and smaller trials; modernizing manufacturing; expanding medical affairs and research activities; and initiating seven well-designed, company-sponsored randomized, controlled clinical studies, targeting combined enrollment of nearly 1,100 patients.2
Significant Clinical Evidence Supports the Efficacy of Acthar Gel
There is significant clinical evidence to support the effectiveness of Acthar Gel. This evidence is the result of company-sponsored controlled clinical trials, investigator-initiated research conducted in top hospitals and medical centers by some of the country's preeminent physicians, and health economic and outcomes research data. Equally important, there are decades of clinical experience that doctors have with the product as a proven therapy for appropriate patients.
As an FDA-approved drug, Acthar Gel is deemed safe and effective for its labeled indications by the agency. Since acquiring Acthar Gel, Mallinckrodt has, though, continued to conduct post-approval clinical studies in a number of key indications. Along with the wealth of clinical experience gained over the decades with this drug, this data will assist physicians in the use of Acthar Gel in the most appropriate patient populations.
On February 5, 2019, Mallinckrodt provided a data update on its Phase 4 Acthar Gel clinical trial in patients with rheumatoid arthritis (RA) and reported the open-label phase of the study was completed. Additional details on the RA clinical trial were also provided on May 2, 2019.
Past statements on various Acthar Gel-related topics can be found here.
1The FDA conducted a thorough review of the label for Acthar Gel in 2010.
2The ongoing clinical studies are referenced below. Each link takes you to details about the study that can be found on www.clinicaltrials.gov. These important investments will build upon the existing body of clinical evidence to support the effectiveness of Acthar Gel.
• Phase 4 trial in Uveitis
• Phase 4 trial in Pulmonary Sarcoidosis
• Phase 4 trial in Multiple Sclerosis Relapse
• Phase 4 trial in Lupus
• Phase 4 trial in Rheumatoid Arthritis
• Phase 4 study in Focal Segmental Glomerulosclerosis (Nephrotic Syndrome)
About Acthar Gel (repository corticotropin injection)
Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information available at Acthar.com.
Each of the stories below provide a view of patients who are taking action to treat their disease or condition with Acthar.