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US approves first drug to delay type 1 diabetes

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US regulators have approved Tzield (teplizumab-mzwv) as the first-ever treatment to delay the onset of clinical type 1 diabetes (T1D).

The decision of the US Food and Drug Administration was praised by diabetes experts as “a historic moment‘ and ‘the beginning of a seismic shiftin how T1D is treated.

The American biopharma’s first-class immunotherapy Provence Bio Inc. has been heralded as the most important breakthrough for the condition since insulin was discovered 100 years ago.

Intravenous infusions once daily for 14 days will now be marketed in the US to delay the onset of stage 3 T1D in adults and children 8 years and older who currently have stage 2 disease.

This follows a study in which Tzield delayed the median onset of stage 3 T1D by approximately two years compared to placebo in patients with stage 2 T1D.

The price for the drug is expected to be announced soon. Provention Bio last month announced a co-promotional deal with pharma giant Sanofi for the US launch.

The breakthrough approval means that for the first time, the immune system attack that is the main cause of T1D can be tackled.

Tzield binds to and inactivates immune cells that attack insulin-producing cells and increases the number of cells that help moderate the immune response.

John Sharretts, director of the division of diabetes, lipid disorders and obesity in the FDA’s Center for Drug Evaluation and Research called it “an important new treatment option” for certain high-risk patients.

He added: “The potential of the drug to delay clinical diagnosis [T1D] can provide patients with months to years without disease burden.”

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An estimated 1.6 million people in the US are already living with T1D, with more than 64,000 new cases diagnosed each year.

The incidence is increasing and the number is expected to exceed five million in the coming decades. It is one of the most common chronic diseases that develop in childhood.

“People with T1D require lifelong insulin replacement therapy, so to be able to give an individual a two-year reprieve from the symptoms and burden of T1D is an amazing achievement as we search for a cure,” said American Diabetes Association. chief scientific and medical officer Robert Gabbay.

The anti-CD3 monoclonal antibody Tzield was evaluated in a randomized study of 76 patients with stage 2 T1D. Participants were randomly given an intravenous infusion of the drug or a placebo for 14 days.

During a median follow-up of 51 months, 45% of the 44 patients receiving Tzield were later diagnosed with stage 3 T1D versus 72% of the 32 placebo-treated patients.

The mean time from randomization to diagnosis of stage 3 T1D was twice as long for patients receiving Tzield compared to placebo, at 50 versus 25 months, a statistically significant difference.

The most common adverse reactions were lymphopenia, rash, leucopenia and headache.

Provention Bio aims to tackle chronic autoimmune diseases by detecting and intercepting asymptomatic diseases and genetic risks at an early stage.

It is also developing a polyvalent coxsackievirus B vaccine for the prevention of T1D and other drug candidates for lupus and celiac disease.

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