Eli Lilly and Boehringer Ingelheim secured approval from the US Food and Drug Administration (FDA) to expand the indications of its diabetes drug Jardience. The new indications include children under 10 with type 2 diabetes, a growing population in recent years. The drug would be the first in its class for patients in this age group, opening up a new avenue for early life diabetes management.
According to Emily Kimber, “The application is supported by results from the phase 3 DINAMO trial, in which Jardiance was associated with a significant reduction in A1c – a marker of average blood sugar – versus placebo in patients aged between ten and 17. When added to other baseline treatments, such as diet, exercise, metformin and/or insulin, Jardiance 10mg and 25mg pooled doses reduced A1c by 0.84% compared with placebo at week 26, the companies reported.”
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(Source: PM Live, March 9th, 2023)