FDA Approves First Drug that Delays Diabetes

Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.

The FDA has approved Provention Bio’s Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes. It is indicated for adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. Tzield is anti-CD3-directed antibody. It binds to CD3, a cell surface antigen present on T lymphocytes, and is believed to deactivate pancreatic beta cell autoreactive T lymphocytes. Tzield is administered by intravenous infusion once daily for 14 consecutive days.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

Tzield will be available by the end of the year at a wholesale acquisition cost of $13,850 per vial for 14-day treatment course list price of $193,900, company executives said in a call with investors. The pricing was based on the value that it brings to patients. “This is a game changing innovation,” Ashleigh Palmer, co-founder and chief executive officer of Provention Bio, said on the call.

In initial conversations with payers, Tzield will likely be available with prior authorization, Jason Hoitt, chief commercial officer, said during the call. He said they don’t anticipate doing any contracting beyond Medicaid. Provention Bio has launched COMPASS, a patient support program; additionally, the company offers financial assistance options and copay assistance to eligible patients for out-of-pocket costs.

People with a type 1 diabetes diagnosis have increased glucose that requires insulin shots or wearing an insulin pump. Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent, brother or sister with type 1 diabetes.

The approval was based on a placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients randomly received Tzield or a placebo once daily via intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis. The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared with 72% of the 32 patients who received a placebo. The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes, according to the FDA.

The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of cytokine release syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield.

In October 2022 the company announced a co-promotion agreement for the U.S. launch of Tzield with Sanofi.