NJ-based Provention Bio has announced that the U.S. FDA has approved its intravenous diabetes drug — the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes in adults and kids with stage 2 type 1 diabetes.
The new drug, branded as Tzield, was evaluated in 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. 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 to 72% of the 32 patients who received a placebo.
Type 1 diabetes 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 they have to wear an insulin pump) to survive and must check their blood sugar levels regularly.
“The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease," said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s CDER.
Tzield — which is administered by intravenous infusion once daily for 14 consecutive days — binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. The drug may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
The drug has a long history. Back in 2007, Eli Lilly and MacroGenics partnered to develop and commercialize teplizumab. Then, in 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly and the drugmaker handed the rights back to MacroGenics. In 2018, Provention in-licensed the drug from MacroGenics and used it as their lead drug for a $56 million IPO filing.
For Provention, the approval is a hard-fought win. The drugmaker first filed its BLA for teplizumab back in January of 2021, but faced some roadblocks a few months later when the FDA uncovered “deficiencies” in the marketing application.More recently, in July, the agency extended the review period for the the drug's BLA by three months.
Last month, Provention announced a co-promotion agreement for the U.S. launch of Tzield with Sanofi.