The first agent indicated for the delay of the onset of stage 3 type 1 diabetes, teplizumab-mzwv (Tzield, Provention Bio) injection, was approved yesterday by FDA. Administered by intravenous infusion once daily for 14 consecutive days, the agent is approved for use in adults and pediatric patients 8 years or older who currently have stage 2 type 1 diabetes. Teplizumab-mzwv is an anti-CD3-directed antibody. In a clinical trial, of patients with stage 2 type 1 diabetes patients, teplizumab-mzwv delayed the median onset of stage 3 type 1 diabetes by 25 months, compared with placebo.
FDA has approved insulin glargine-aglr (Rezvoglar, Lilly), the second interchangeable biosimilar insulin product to Lantus (insulin glargine). Insulin glargine-aglr was approved in Dec. 2021 as a biosimilar to Lantus. This new approval makes Rezvoglar the second approved interchangeable biosimilar insulin in the U.S., joining Semglee (insulin glargine-yfgn), which was approved on July 28, 2021. Rezvoglar is available in 3-mL prefilled pens and is administered subcutaneously once daily.
Twenty-five years after Eisai marketed Aricept for treatment of symptoms of Alzheimer’s disease, the anticipated approval of lecanemab gives the company “a chance to make good on … years of fruitless labor,” Stat reporters write. To succeed, the company had to change the way it conducted clinical trials of the drug. Use of an adaptive trial to test multiple doses in a clinical study long enough to show benefit and large enough to have diversity among patients “was considered impossible in Alzheimer’s [because] the disease progresses too slowly. You wouldn’t know which arms were doing better until the study was basically over,” the reporters write. “Unless, that is, you use Bayesian statistics.… In Eisai’s clinical trial, [this] meant building a sophisticated algorithm that, at numerous moments, would look at how patients had done up to that point and predict how they would be doing at the 12-month mark. It meant linear regressions and longitudinal modeling, Gaussian random walks, Markov chain Monte Carlo methods, and other concepts more likely to be found in mathematical journals than the pages of Nature.”