November marks Diabetes Awareness Month, and this year it arrives after a busy stretch for diabetes therapeutics and technology. Since June, the FDA has approved the first disease-modifying therapy for children recently diagnosed with stage 3 type 1 diabetes (T1D) and a second once-weekly basal insulin for adults with type 2 diabetes (T2D) and has cleared an automated insulin delivery (AID) system for adults with insulin-treated T2D. Each changes how patients take therapy or track their response, and each opens new counseling opportunities for pharmacists.
Teplizumab Moves Into Stage 3 T1D
On June 12, 2026, the FDA granted accelerated approval to teplizumab-mzwv (Tzield; Sanofi) to delay the decline of endogenous insulin production in patients aged 8 to 17 years who were recently diagnosed with stage 3 T1D. The agent was previously approved to delay the onset of stage 3 disease in adults and pediatric patients aged 1 year and older with stage 2 T1D.1
The approval rests on the phase 3 PROTECT trial (NCT03875729), which randomly assigned 328 participants diagnosed within the preceding 6 weeks 2:1 to teplizumab or placebo. Teplizumab slowed the decline in C-peptide, a marker of residual beta-cell function, versus placebo (difference in least-squares means, 0.13 pmol/mL; 95% CI, 0.09-0.17; P < .001). Because C-peptide is a surrogate end point, continued approval may depend on the confirmatory BETA-PRESERVE trial (NCT07088068).2
In PROTECT, participants received 2 courses of 12 daily infusions, 26 weeks apart. Pharmacists supporting infusion services should know the most common adverse reactions, including lymphopenia, rash, leukopenia, and elevated liver transaminases, as well as serious risks such as cytokine release syndrome and viral reactivation.2
A Second Once-Weekly Basal Insulin
In September, Eli Lilly announced FDA approval of insulin efsitora alfa-gobe (Onswik), used with diet and exercise, for adults with T2D.3,4 It follows insulin icodec-abae (Awiqli; Novo Nordisk)—which was approved in March 2026—as the second once-weekly basal insulin for this population.3
