FDA approves drug that can delay Type 1 diabetes

The Food and Drug Administration has approved the first treatment that can delay — possibly for years — the onset of Type 1 diabetes, a disease that often emerges in teenagers.

The new drug, teplizumab, is made by Provention Bio, which will partner with Sanofi to market the drug in the United States under the brand name Tzield. In an investor call on Friday, Provention said the drug would cost $13,850 a vial or $193,900 for the 14-day treatment. The company said teplizumab should be available by the end of the year.

The drug, which the FDA approved Thursday, does not cure or prevent Type 1 diabetes. Instead, it postpones its onset by an average of two years and, for some lucky patients, much longer — the longest so far is 11 years, said Dr. Kevan Herold of Yale, a principal investigator in trials of the drug.

The only other treatment for the disease — insulin — was discovered 100 years ago and does not affect the course of the disease. It just replaces what is missing.

Teplizumab will be used to treat patients at high risk for Type 1 diabetes who have antibodies that indicate an immune attack on their pancreas and whose glucose tolerance is not normal. Treatment involves a 14-day infusion of the drug, a monoclonal antibody that blocks T cells, preventing them from attacking the insulin-producing cells of the pancreas.

“Talk to anyone who has Type 1 diabetes and any day you are not burdened by measuring blood sugar four times a day and injecting yourself with insulin is a glorious day,” said Dr. Mark S. Anderson, director of the diabetes center at the University of California, San Francisco, and a researcher for the pivotal clinical trial that led to the treatment’s approval. Dr. Anderson has been a paid consultant for Provention in the past.

Dr. John Buse, a diabetes expert at the University of North Carolina who was not involved in the study, called the approval “really exciting” and said it would “turn the world of Type 1 diabetes on its head.”

“There has always been a notion that screening would be a good idea,” he said. But medical experts “have never really promoted it to detect Type 1 diabetes.”