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FDA Declines to Approve Application for Long-Acting Injection Targeting MS
The US Food and Drug Administration (FDA) has declined to approve glatiramer acetate depot 40mg (GA Depot 40), a long-acting investigational formulation of glatiramer acetate for the treatment of relapse-remitting multiple sclerosis (RRMS).
Drug manufacturers Viatris and Mapi Pharma announced on March 11 that they had received a complete response letter (CRL) from the FDA. They are currently reviewing the “appropriate next steps” for the novel formulation. Neither the companies nor the FDA have offered further details behind the decision to decline approval. Notably, a CRL from the health regulator is not a full-throated rejection; rather, it is a notice that the FDA will not approve the drug application in its present form. Application sponsors have the option to resubmit for review, though approval is not guaranteed.
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Unlike Teva’s thrice-weekly glatiramer acetate subcutaneous injection (Copaxone), GA Depot is designed to be administered as an intramuscular injection once every 4 weeks. The drug’s application was supported by data from a Phase 3 clinical trial (NCT04121221) that involved 1016 adults aged 18-55 with RRMS or active secondary progressive multiple sclerosis (SPMS). Patients were randomly assigned to receive GA Depot 40 or placebo once a month for a year, comprising 13 injections. The trial met its primary endpoint, demonstrating that GA Depot “significantly reduced relapse rated by 30.1% relative to the placebo.” Researchers also reported a slowed rate of disability accumulation and reductions in brain lesions compared with placebo.
Additionally, a total 763 study participants accepted the option to enter an open-label extension phase. Initial findings presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 included a favorable safety profile, with mild to moderate side effects, as well as a much lower rate of side effects experienced in the second year of treatment versus the first. A significantly higher proportion of patients also reported a maintained or improved quality of life after 2 years of treatment. An additional ongoing, open-label Phase 2 clinical trial (NCT03362294) continues the evaluation of GA Depot’s safety and efficacy.
“The Companies continue to believe in the potential of the product to provide an important new treatment advancement for patients with multiple sclerosis,” Viatis and Mapi Pharma emphasized in their joint press release.
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