FDA Issues CRL for Glatiramer Acetate Depot for Relapsing Forms of MS


The FDA has declined to approve glatiramer acetate (GA) depot in the treatment of relapsing types of multiple sclerosis (MS), issuing a complete response letter (CRL) for the long-acting, injectable form of GA.

The FDA has issued a complete response letter (CRL) for glatiramer acetate (GA) depot for the treatment of patients with forms of relapsing multiple sclerosis (MS).1 GA depot is an injectable, once-a-month, long-acting form of GA developed by Viatris and Mapi Pharma, and the application was for the approval of GA depot at a dosage of 40 mg.2 Next steps will be determined as each company reviews the CRL.1

The new drug application filing for GA depot was supported by results from a phase 3, multinational, placebo-controlled, double-blind clinical trial (NCT04121221).3 The study separated 1106 participants into 2 cohorts, either receiving a placebo or GA depot at a dose of 40 mg. Patients underwent a total of 13 intramuscular injections over 52 weeks: 1 every 4 weeks. Included participants had recorded at least 1 relapse in the previous year.

This intervention significantly reduced the rate of annual relapses by over 30% compared with placebo (P = .0066) and, additionally, created a more favorable schedule for patients who also experienced less reactions at the injection site compared with other GA medications.

FDA on Paper Texture | Image credit: Araki Illustrations -

FDA on Paper Texture | Image credit: Araki Illustrations -

An estimated 1 million people in the US are living with MS, more than doubling previous estimations, according to the National Multiple Sclerosis Society. Among those with MS, around 85% are initially diagnosed with relapsing MS, indicating the need for interventions such as GA depot.

At present, GA depot is also being evaluated in a phase 2 trial (NCT03362294) focused on patients with primary progressive MS.4 One-year data were previously presented at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting, with results suggesting a favorable efficacy and safety profile as patients demonstrated stable Expanded Disability Status Scale scores and experienced infrequent adverse events.5 Just over 69% of those treated with GA Depot were observably progression-free after 12 months.


1. US FDA declines to approve Viatris's injection for multiple sclerosis. Reuters. March 11, 2024. Accessed March 11, 2024.

2. FDA sets PDUFA date for monthly MS drug. Formulary Watch. August 8, 2023. Accessed March 11, 2024.

3. Viatris and Mapi Pharma announce FDA acceptance of new drug application filing for GA depot for the treatment of relapsing forms of multiple sclerosis. News release. Viatris. August 7, 2023. Accessed March 11, 2024.

4. Safety and efficacy of monthly long-acting IM injection of 25mg or 40 mg GA depot in subjects with PPMS. Updated November 15, 2023. Accessed March 11, 2024.

5. Fletcher S, Kimelman NB, Danon U, et al. Glatiramer acetate depot (extended release) phase 2a study in patients with primary progressive multiple sclerosis: safety and efficacy 1 year interim snapshot analysis. Presented at: CMSC Annual Meeting; June 1-4, 2022; National Harbor, MD. Poster 8374.

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