Tzield (teplizumab), a once-daily injection to delay the onset of stage 3 type 1 diabetes in adults and paediatric patients 8 years and older who are currently in stage 2 type 1 diabetes has been approved today by the US Food and Drug Administration (FDA).
A clinical trial discovered that teplizumab can postpone type 1 diabetes by an average of three years in people who are at high risk of developing the disease. It can now be prescribed to people at risk of type 1 diabetes in the United States.
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Type 1 diabetes is a condition in which the immune system attacks and destroys insulin-producing cells.
Tzield delays the progression to stage 3 type 1 diabetes by attaching itself to particular immune system cells.
This landmark approval makes Tzield the first FDA approved immunotherapy.
Immunotherapies are used to treat a number of autoimmune diseases like psoriasis and rheumatoid arthritis.
It is hoped they may be able to to halt or completely prevent type 1 diabetes in the future.
Tzield is administered by intravenous infusion once daily for 14 consecutive days.
Chris Askew OBE, Chief Executive at Diabetes UK, said: “The licensing of teplizumab in the UK must now be accelerated, and we’re working with the NHS and with other diabetes charities and key stakeholders to ensure that people in the UK can benefit from this life-changing treatment as soon as possible.”
The FDA granted Breakthrough Therapy Designation to the drug in 2019 after it became the first medication to demonstrate the delay of type 1 diabetes onset.
The announcement follows the launch of a landmark trial to screen children with type 1 diabetes in the UK.