EMA approval for Teva’s long-acting recombinant G-CSF

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EMA approval for Teva’s long-acting recombinant G-CSF

Biosimilars/News | Posted 23/08/2013 0 Post your comment

The European Medicines Agency (EMA) has granted marketing authorization for a new long-acting filgrastim – Lonquex (XM22 lipegfilgrastim) – to prevent chemotherapy-induced neutropenia in cancer patients.

The recombinant granulocyte colony-stimulating factor (G-CSF), which includes the active ingredient lipegfilgrastim, was developed by Israel-based generic drugmaker Teva Pharmaceutical Industries (Teva), and was authorized eight weeks after receiving a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP).

Because it is ‘glycopegylated’ (rather than peglylated) polymer chains are added to the active protein that are distant from the active site. In theory, this should prevent variations in the activity of the drug molecule and increase its structural homogeneity.

Last year, FDA granted approval for Teva’s tbo-filgrastim (XM02 filgrastim), the first new G-CSF to be approved in the US in more than 10 years [1].

The marketing authorization of Lonquex (lipegfilgrastim) provides clinicians with another long-acting G-CSF treatment choice when managing the effects of chemotherapy-induced neutropenia (CIN) in patients with cancer in Europe. CIN is a potentially life-threatening side effect of cancer chemotherapy, caused by a drop in neutrophil numbers and corresponding susceptibility to bacterial infections.

Guidelines from the European Organisation for Research and Treatment of Cancer (EORTC) recommend prophylactic G-CSF treatment for chemotherapy patients with an overall high risk (≥ 20%) of developing febrile neutropenia to help avoid the risks associated with a low neutrophil count [2].

Lonquex will compete in the marketplace with Neulasta (pegfilgrastim, Amgen) and will be dosed in the same way as a single subcutaneous injection once per chemotherapy cycle. Lonquex was shown to be non-inferior to Neulasta in trials, although there was no evidence of advantages over the Amgen drug.

Teva markets another biosimilar version of Neupogen (filgrastim) in Europe, together with Sandoz and Hospira, but this latest approval of the new drug Lonquex provides Teva with a significant advantage over its competitors.

References

1. GaBI Online - Generics and Biosimilars Initiative. Teva receives FDA approval for filgrastim in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/Teva-receives-FDA-approval-for-filgrastim-in-the-US

2 Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8-32.

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Source: EMA, Teva