FDA approves subcutaneous tocilizumab for polyarticular JIA

 

The Food and Drug Administration approved a subcutaneous version of tocilizumab as a treatment for polyarticular juvenile idiopathic arthritis (PJIA) in patients aged 2 years and older, according to a statement released May 14 by the drug’s manufacturer, Genentech.

While a intravenous formulation of the treatment was approved in 2013, this new delivery method may help make this treatment more accessible to the approximately 30 in every 100,000 children affected by PJIA, according to the release.

The approval is based on findings from a 52-week, phase 1b, multicenter study of 52 PJIA patients aged 1-17 years, treated with open-label tocilizumab (Actemra).

Doses were determined based on weight. Patients under 30 kg received 162 mg of tocilizumab every 3 weeks, while those 30 kg and over received 162 mg tocilizumab every 2 weeks.

Overall, safety of the subcutaneous delivery method was consistent with the IV study, as was the efficacy of the drug, the company said. A total of 28.8% of patients reported injection-site reactions – all moderate – and 15.4% reported neutrophil counts below 1 x 109 per liter.Tocilizumab can be taken either by itself or with methotrexate.

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The Food and Drug Administration approved a subcutaneous version of tocilizumab as a treatment for polyarticular juvenile idiopathic arthritis (PJIA) in patients aged 2 years and older, according to a statement released May 14 by the drug’s manufacturer, Genentech.

While a intravenous formulation of the treatment was approved in 2013, this new delivery method may help make this treatment more accessible to the approximately 30 in every 100,000 children affected by PJIA, according to the release.

The approval is based on findings from a 52-week, phase 1b, multicenter study of 52 PJIA patients aged 1-17 years, treated with open-label tocilizumab (Actemra).

Doses were determined based on weight. Patients under 30 kg received 162 mg of tocilizumab every 3 weeks, while those 30 kg and over received 162 mg tocilizumab every 2 weeks.

Overall, safety of the subcutaneous delivery method was consistent with the IV study, as was the efficacy of the drug, the company said. A total of 28.8% of patients reported injection-site reactions – all moderate – and 15.4% reported neutrophil counts below 1 x 109 per liter.Tocilizumab can be taken either by itself or with methotrexate.

[email protected]

 

The Food and Drug Administration approved a subcutaneous version of tocilizumab as a treatment for polyarticular juvenile idiopathic arthritis (PJIA) in patients aged 2 years and older, according to a statement released May 14 by the drug’s manufacturer, Genentech.

While a intravenous formulation of the treatment was approved in 2013, this new delivery method may help make this treatment more accessible to the approximately 30 in every 100,000 children affected by PJIA, according to the release.

The approval is based on findings from a 52-week, phase 1b, multicenter study of 52 PJIA patients aged 1-17 years, treated with open-label tocilizumab (Actemra).

Doses were determined based on weight. Patients under 30 kg received 162 mg of tocilizumab every 3 weeks, while those 30 kg and over received 162 mg tocilizumab every 2 weeks.

Overall, safety of the subcutaneous delivery method was consistent with the IV study, as was the efficacy of the drug, the company said. A total of 28.8% of patients reported injection-site reactions – all moderate – and 15.4% reported neutrophil counts below 1 x 109 per liter.Tocilizumab can be taken either by itself or with methotrexate.

[email protected]