The FDA Just Approved The World's First Once-A-Week Insulin
The Food and Drug Administration has approved the world's first once-weekly basal insulin for adults with type 2 diabetes, a development that physicians are already calling groundbreaking for its potential to make insulin treatment dramatically more manageable for the millions of people who currently inject it every single day. The drug, called Awiqli and developed by Novo Nordisk under the clinical name insulin icodec, is administered just once a week using the company's FlexTouch device and is expected to be available in pharmacies across the United States in the second half of this year. It is already approved in the European Union and 13 other countries including Canada, Australia, and Japan, and its approval in the US was based on results from a phase 3 clinical trial program involving nearly 2,700 adults with uncontrolled type 2 diabetes, in which the weekly injection demonstrated significant reductions in blood sugar levels with a consistent and tolerable safety profile compared to daily basal insulin.
For patients, the practical significance is hard to overstate. More than 37 million Americans have diabetes, and many of those who require insulin must inject it daily, a routine that can be difficult to maintain consistently and that creates a real barrier to starting insulin therapy for people who are reluctant to commit to daily injections. A clinical pharmacist involved in diabetes care said the approval is groundbreaking because the frequency of injections is one of the biggest obstacles to insulin use, and that a weekly insulin will help many patients who currently miss doses or hesitate to begin treatment in the first place. For people who rely on caregivers to administer their insulin, moving from a daily to a weekly schedule will significantly reduce the burden on both patient and caregiver. The drug is not yet approved for type 1 diabetes, where more data is needed, but its arrival for type 2 represents the biggest shift in how basal insulin is delivered since the long-acting daily formulations that replaced multiple daily injections decades ago.
