With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
Pictured: A nerve cell attacked by the immune system/iStock, peterschreiber.media
The FDA has rejected Viatris and Mapi Pharma’s investigational formulation of glatiramer acetate, dubbed GA Depot 40, for the treatment of relapsing forms of multiple sclerosis, the companies announced on Monday.
Details of the FDA’s rejection were scant and the partners only said that they are currently reviewing the Complete Response Letter to better determine the “appropriate next steps” for GA Depot 40.
“The companies continue to believe in the potential of the product to provide an important new treatment advancement for patients with multiple sclerosis,” according to the announcement.
Glatiramer acetate, the active ingredient of GA Depot 40 is an immunomodulator that targets the inflammatory pathways underpinning multiple sclerosis (MS). The drug itself cannot cross the blood-brain barrier but exerts its effects through peripheral helper cells, which can then potentially enter the brain and reduce inflammation within the central nervous system.
Originally developed by Teva Pharmaceuticals, glatiramer acetate was first approved in the U.S. in 1996 for the treatment of relapsing forms of MS. It carries the brand name Copaxone.
Viatris and Israel-based partner Mapi were proposing their investigational long-acting formulation of glatiramer acetate, which is designed to be given via an intramuscular injection every four weeks.
The partners supported their New Drug Application, which the FDA accepted in August 2023, with Phase III data obtained from more than 1,000 patients who received a total of 13 doses of either 40-mg GA Depot or placebo. Results showed that the long-acting formulation could cut the annualized relapse rate by 30.1% versus placebo, an effect that was statistically significant with a p-value of 0.0066.
GA Depot also offered patients a preferable dosing schedule and elicited fewer injection site reactions as compared with other products.
At the time, Viatris President Rajiv Malik said in a statement that GA depot, if approved, could “improve patient experience through fewer injections, greater tolerability and increased compliance.”
Monday’s rejection continues biopharma’s losing streak in the MS space. Last week, Merck KGaA announced that it was abandoning the development of its BTK inhibitor evobrutinib in MS. The decision comes after the candidate failed two Phase III trials in December 2023, unable to significantly reduce annualized relapse rate versus teriflunomide.
Other BTK inhibitors have also stumbled in MS. Sanofi’s tolebrutinib was put under partial clinical hold in June 2022 due to drug-induced liver injury. Roche’s candidate fenebrutinib ran into the same problem in December 2023, when the FDA also put a regulatory pause on the BTK inhibitor for potential liver injury.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
