FDA, USA, Approves Higher Doses of Dulaglutid (Trulicity®) To Help People with Type 2 Diabetes
The FDA approved higher doses of the GLP-1 agonist, Trulicity, after powerful clinical trial results showed that the increased medication can help people lower their A1C and lose weight
The FDA approved two additional doses of Trulicity, a GLP-1 agonist drug. Lilly’s Trulicity is a once-weekly injectable treatment for type 2 diabetes that lowers blood sugar levels and supports weight loss.
Until now, the approved doses for Trulicity were 0.75 mg and 1.5 mg per week, delivered in a single use auto-injector. While previous dose options are still available, expanded doses may be helpful for some people with type 2 diabetes: the 4.5 mg dose reduced A1C by 1.9 percentage points, and led to an average weight loss of 10.4 pounds! Talk to your healthcare professional to find out if a higher dose is right for you.
The FDA approved 3.0 mg and 4.5 mg doses of Trulicity, based on results from the AWARD-11 clinical trial. The trial evaluated higher doses of Trulicity after 36 weeks and found that:
- The 3.0 mg dose reduced A1C by 1.7 percentage points or 17 mmol/mol, and led to an average weight loss of 8.8 pounds or 4 kg.
- The 4.5 mg dose reduced A1C by 1.9 percentage points or 19 mmol/mol , and led to an average weight loss of 10.4 pounds or 4,7 kg.
- The previously approved 1.5 mg dose reduced A1C by 1.5 percentage points or 15 mmol/mol, and led to an average weight loss of 6.8 pounds or 3,1 kg.
Similar effects were also seen after 52 weeks, further confirming consistent treatment effects from taking Trulicity at higher doses.
This is an exciting step forward for people with type 2 diabetes. Given that diabetes care often requires adjustments to treatment over time, more options that reduce blood glucose levels and promote weight loss are helpful when current treatments are not enough. Plus, Trulicity prevents heart disease.
Earlier this year Trulicity was approved by the FDA to reduce the risk of stroke and heart attack for adults with type 2 diabetes and pre-existing heart disease, or at risk for heart disease. This makes Trulicity the only diabetes drug approved for the primary prevention of heart disease in people with type 2 diabetes!
The increased doses of Trulicity are expected to be available in pharmacies in the United States later this month (September).
The AWARD-11 trial results are currently being reviewed by the European Medicines Agency (EMA), and Lilly expects a recommendation decision on expanded doses in the EU by the end of 2020.
From www.diatribe.org
Kommentar
Enligt uppgift finns en EU-ansökan inlämnad för de högre doserna. Om s.k. positive opinion i slutet av nästa vecka i samband med CHMPs månadsmöte, då skulle dessa högre doser kunna bli godkända i november och kunna göras tillgängliga tidigt nästa år i Sverige.
Se också 2020 07 03
Dulaglutid (Trulicity), första GLP-1 med prim och sek prev CVD T2DM
AWARD-11
https://diabetes.diabetesjournals.org/content/69/Supplement_1/357-OR
357-OR: Efficacy and Safety of Dulaglutide 3mg and 4.5mg vs. Dulaglutide 1.5mg: 52-Week Results from AWARD-11
Nyhetsinfo
www red DiabetologNytt
