FDA has approved Teva’s supplemental new drug application (sNDA) for a three-times-a-week version of Copaxone (40 mg/mL), which will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis.

The new Copaxone formulation reduces the number of injections by 60%. The company quotes Omar Khan, Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, who says that this ‘is a significant advancement for [US] patients’ who ‘can now benefit from an improved dosing regimen without compromising the known benefits of Copaxone’.

The FDA approval is based on data from the phase III Glatiramer Acetate Low-frequency Administration (GALA) study of more than 1,400 patients, which showed that a 40 mg/mL dose of Copaxone administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favourable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis.

The FDA approval comes as good news for Teva, who had several of its Copaxone patents invalidated by a US Federal Circuit Court of Appeals ruling, which could open the drug up to generics competition as early as May 2014 [1]. Although the company states that its daily Copaxone version (20 mg/mL) will continue to be available, it would be advantageous for the company to switch patients from daily to weekly Copaxone before generics of the daily version hit the market.

Copaxone is classified as a non-biological complex drugs (NBCD), but since there are currently no guidelines for ‘follow-on’ versions of NBCDs such drugs are approved under the generics pathway. Teva is also arguing that given the complexity of Copaxone the only way ‘to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS [relapsing-remitting multiple sclerosis] patients’. They add that ‘differences between a proposed generic drug product and Copaxone could lead to immunogenic effects in patients’.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Teva loses fight against generic glatiramer acetate [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 14]. Available from: www.gabionline.net/Generics/News/Teva-loses-fight-against-generic-glatiramer-acetate

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