The United States Food and Drug Administration’s green light to teplizumab injection to prevent progression of type 1 diabetes in a select population, is being seen as a game-changer of sorts.

The breakthrough therapy is expected to open the flood-gates for more such products, veteran diabetologists said, adding however, the new therapy is a preventive in a limited population and should not be viewed as a cure.

The therapy is useful as a preventive in siblings or relatives of those with type 1 diabetes, who have been tested and found to have the potential of getting diabetes as well, explains diabetologist Dr V Mohan, Chairman, Mohan’s Diabetes Specialties Centre. The advantage is that it makes people aware and delays the onset of the disease, but the downside includes its effect on immunity, and the price at which it will be sold, if it is brought to India as some point.

Type 1 diabetes is largely an auto-immune disease and about 60 percent of this population are children. India is home to the second-largest population of people with diabetes in the world (estimated 77 million), but it has the highest number of those with type 1 disease (estimated at over 2 lakh), experts point out.

Tzield injection to delay onset

The recently-approved therapy is a ray of hope in delaying disease progression in a select population, explains diabetologist Dr Shashank Joshi, adding emphatically, it is not part of the treatment module for type 1 diabetes. “The `insulin for life’, saying remains” he said, urging people to not stop their insulin and speak to their endocrinologist for clarity. Dr Joshi is Chair, International Diabetes Federation, South East Asian Region.

The US regulator had on Thursday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. The approval on the therapy was given to Provention Bio.

“Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days,” the USFDA said.

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People with a type 1 diabetes diagnosis have increased glucose that requires insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day, the US agency explained.

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