Weekly insulin analogues approaching approval could herald change

18 Apr 2024
www.pharmaceutical-technology.com
Phase 3Drug ApprovalClinical ResultPhase 2
Weekly insulin analogues approaching approval could herald change
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Source: Pharmaceutical Technology
Diabetologist doctor teaching a teenage patient how to inject insulin into her abdomen, using insulin pen. Weekly insulin treatments could mean a lower burden on patients. Image Credit: Getty Images/ Halfpoint Images
Upcoming weekly insulin candidates can reduce the injection burden on patients with diabetes and ease the load on healthcare resources, said Anna Hodgkinson, a specialist diabetes pharmacist at an ongoing diabetes conference in London.
Hodgkinson, who works at at the Lambeth DiabetesDiabetes Intermediate Care Team, called particular attention to Novo Nordisk’s Awiqli (insulin icodec) and Eli Lilly’s LY3209590 (insulin efsitora alfa), both of which are weekly insulin candidates that may be available on the market shortly. She was speaking at a talk at the Diabetes UK conference on 17 April. The conference closes on 19 April.
Despite the benefits, Hodgkinson raised questions about whether Awiqli’s long half-life may prolong the time required for insulin clearance. The therapy is still yet to be tested in chronic kidney disease patients, Hodgkinson added.
Awiqli is a long-acting basal insulin analogue with a half-life of 196 hours (8.1 days). Its treatment regimen involves three to four weeks of weekly injections before patients reach steady state. Related to the dose, Hodgkinson said, “As a pharmacist, we get worried about high-strength insulin. This is 700 units/ml (Icodec) which makes me nervous.”
LY3209590 has a half-life of 17 days and it allows patients to achieve a steady state in a six-week timespan. On 27 February, Lilly announced the completion of the Phase III QWINT-4 study (NCT05462756), comparing LY3209590 with insulin glargine in adult patients with type 2 diabetes on multiple daily injections. The pharma giant is currently also investigating the therapy’s use on insulin-naïve patients in the QWINT-1 (NCT05662332) and QWINT-2 trials (NCT05362058).
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Weekly insulin analogues approaching approval could herald change
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Source: Pharmaceutical Technology
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended Awiqli for approval, based on results from the Phase IIIa ONWARDS 1 (NCT04460885) and another Phase III clinical trial (NCT04795531), on March 22. Study data demonstrated that in the treatment group, more insulin-naïve adults with type 2 diabetes treated with Awiqli had reduced blood glucose levels without experiencing clinically significant or severe hypoglycaemia, in comparison with the once-daily basal insulin group.
Novo Nordisk submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for Awiqli. The company anticipates a decision from the agency in April 2024.
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