Once-weekly basal insulin "Awiqli" close to EU approval

[Eddy Edson]

https://ml-eu.globenewswire.com/Resource/Download/af92bdbe-776d-431e-bbc7-29d60a4e5a43

Bagsværd, Denmark, 21 March 2024 – Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli® (the brand name for once weekly basal insulin icodec) for treatment of diabetes in adults.

The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trialp rogramme. Once-weekly basal insulin icodec achieved superior blood sugar reduction1(measured by a change in HbA1c) and superior Time in Range2(time spent within recommendedblood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have not previously been treated with insulin, overall observed ratesof clinically significant or severe hypoglycaemia3 were below one event per patient-year ofexposure with both once-weekly basal insulin icodec and comparators. In people with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec4. Across the programme, once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile.“We believe that by reducing the number of basal insulin injections from seven to one per week,Awiqli® has the potential to have a significant impact and improve treatment for people living with diabetes,” said Martin Holst Lange, executive vice president for Development at NovoNordisk. “We are committed to driving innovation in diabetes treatment, and Awiqli® has thepotential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months

 

[everydayupsanddowns]

We believe that by reducing the number of basal insulin injections from seven to one per week,Awiqli® has the potential to have a significant impact and improve treatment for people living with diabetes,

Good to hear the results seemed so promising for T2 in terms of TIR and HbA1c reduction. I have no idea why the obsession with ultra-mega-super-duper-long-acting still seems to be such a major focus for the drug manufacturers.

Sounds like a complete nightmare to me! Can you imagine trying to run a basal check when it lasts a week 😱

Am I right in reading the doublespeak for T1s as resulting in more hypos and no better HbA1c than Levemir?

 

[Eddy Edson]

Am I right in reading the doublespeak for T1s as resulting in more hypos and no better HbA1c than Levemir?

Hence the "Awiqli® has thepotential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment" statement, I guess?

 

[Bruce Stephens]

Hence the "Awiqli® has thepotential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment" statement, I guess?

But it sounds like it's not a terrible option for people with Type 1 so I can imagine it being occasionally used. Does sound like it won't be that popular. But yes, I'm sure it's intended mostly for Type 2.

 

[rebrascora]

Am I right in reading the doublespeak for T1s as resulting in more hypos and no better HbA1c than Levemir?

I think Degludec is Tresiba. So they are comparing the current longest acting insulin with the new ultralong acting insulin, as oppose to comparing it to the shortest acting basal Levemir which is Detemir.

 

[everydayupsanddowns]

Ooops! Yes you are right @rebrascora sorry!

It slightly irritates me that we have to remember pairs of names for all these things. Too many made up words for my tiny brain!

 

[rebrascora]

Ooops! Yes you are right @rebrascora sorry!

It slightly irritates me that we have to remember pairs of names for all these things. Too many made up words for my tiny brain!

I agree, it is very confusing. I have to say, I wasn't certain and had to look up Degludec to confirm it was Tresiba. It makes sense though to compare it to the longest acting basal they currently have rather than the shortest. I could imagine that I wouldn't get much sleep and would put on a lot of weight from all the jelly babies I had to eat every night to keep me out of the red with something like that or I would need MASSIVE amounts of FIasp during the day if my basal dose was scaled right back to prevent the nocturnal hypos. If it works for Type 2s then great but I wonder what sort of doses they would need to inject at one go to inject enough to last a week and what implications that might have considering that many Type 2s need much larger doses to overcome insulin resistance sometimes amounting to hundreds of units on a daily basis.

 

[Lucyr]

Have they chosen the name by just going with how badly you can spell “a weekly”? I’m guessing it’s pronounced like that just said fast