Cross-Compatibility Issues With Autoinjectors Highlighted in New FDA Labeling Update of Glatiramer Acetate Injection

The FDA has issued an update to the labeling of glatiramer acetate injection products, with a new warning label that highlights cross-compatibility issues with the use of autoinjectors. In the update, the agency also alerted patients and health care professionals that some specific glatiramer acetate injection therapies may be administered using an optional compatible autoinjector, while other glatiramer acetate injection products must only be injected using the prefilled syringe.

The increased risk for medications errors, such as a missed dose or administration of a partial dose, was the basis behind the updated labeling for these autoinjectors. The agency noted it will not further update the table of glatiramer acetate injection products and their optional compatible autoinjector devices included in the CDER Alert originally issued in August 2022.

The 3 approved products include Teva’s Copaxone (glatiramer acetate injection), Sandoz’s Glatopa (glatiramer acetate injection), and Viatris/Mylan’s Glatiramer Acetate injection. According to the FDA, there are no compatible autoinjector devices available for Copaxone; however, the availability of optional compatible autoinjectors for each glatiramer acetate injection product may change with time. For Glatopa and Viatris/Mylan’s Glatiramer Acetate, patients have the option to use the Glatopaject and WhisperJECT, respectively, as a compatible autoinjector device.

In the update, the agency wrote, "Patients can continue to confirm the compatibility of their autoinjector by speaking with their health care professional, visiting the drug manufacturer's patient information website, contacting the drug manufacturer for more information, or referring to the autoinjector labeling. Patients should also continue to confirm their autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product."

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Glatiramer acetate injection is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Despite an unclear understanding of its mechanism, the therapy appears to influence immune processes associated with MS. Although unable to breach the blood-brain barrier, glatiramer acetate prompts peripheral Th2 cells, facilitating their traversal across the blood brain barrier and reducing inflammation within the central nervous system.

There is another glatiramer acetate solution currently in the pipeline that received a complete response letter (CRL) from the FDA earlier this year.³ Viatris and Mapi Pharma’s GA Depot, a long-acting, once-monthly glatiramer acetate formulation, was under review for several months before receiving the CRL in March. The agency originally accepted the new drug application (NDA), which comprised of data from a phase 3, multinational, double-blind, placebo-controlled study (NCT04121221) of GA Depot in November 2023.

In the trial, treatment with GA Depot led to statistically significant reduction of annualized relapse rate (ARR) relative to placebo (P = .0066) over a 52-week period. Findings from the study were strengthened by MRI end points as well. At 52 weeks, patients on the therapy demonstrated 28.5% reduction in cumulative new enhancing T1 lesions (P = .0083) and a 17.3% reduction of cumulative number of new or newly enlarging hyperintense T2 lesions (P = .0305). Additionally, treatment with the therapy resulted in consistently and statistically significant (P = .0193) reductions in mean Expanded Disability Status Scale (EDSS) scores.⁴

REFERENCES
1. FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection. News release. FDA. May 16, 2024. Accessed May 16, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector?utm_medium=email&utm_source=govdelivery
2. Babaesfahani A, Patel P, Bajaj T. Glatiramer. National Library of Medicine. Updated February 28, 2024. Accessed May 16, 2024. https://www.ncbi.nlm.nih.gov/books/NBK541007/
3. Viatris and Mapi Pharma Statement Regarding New Drug Application for GA Depot. News Release. Viatris. Published March 11, 2024. Accessed March 11, 2024. https://newsroom.viatris.com/press-releases?item=123816
4. Miller AE, Popper L, Berger JR, et al. Results of a Phase III, Multinational, Double Blind, Placebo-Controlled Study in Subjects with Relapsing Forms of Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of GA Depot, a Long-Acting IM Injection of Glatiramer Acetate, Administered Once Every Four Weeks. Presented at ACTRIMS Forum 2023; February 23-25; San Diego, California. Abstract P087.