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Articles

Safety in Lactation: Other antidiabetic drugs

18 September 2020There is no published information on the use of these other antidiabetic drugs during breastfeeding. Therefore, alternative drugs should be used where this is clinically…

Cardiovascular outcomes with GLP-1 receptor agonists

28 May 2019This document reviews the evidence from the major cardiovascular clinical trials for GLP-1 receptor agonists.
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Refrigerated Storage

VictozaNovo Nordisk

Novo Nordisk
Victoza
6 mg/ml solution for injection in pre-filled pen

The manufacturer does not hold stability data in addition to that provided in the Summary of Product Characteristics (SPC). Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

21 July 2020
London MI service

Lactation Safety Information

Exenatide
Likely to be degraded in infant's GI tract
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
16 September 2020

New Medicines

SaxendaObesity in children aged 12 to 17 years

Information

Saxenda
Licence extension / variation
Novo Nordisk
Novo Nordisk

Development and Regulatory status

None
Approved (Licensed)
Launched
Jun 21Licence extension approved in EU [10].
Mar 21Recommended for EU approval by CHMP - the additional indication is "as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg." Treatment ... should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *IOTF BMI cut-off points for obesity by sex between 12–18 years [8].
Dec 20The FDA has approved an updated label for liraglutide injection 3 mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 [7].

Category

Glucagon-like peptide-1 (GLP-1) analogue - 3mg dose
In 2016, the Health Survey for England found that 23% of children aged 11 to 15 were obese, with a higher rate of obesity observed in boys (26%) compared to girls (20%) [1].
Obesity in children aged 12 to 17 years
Subcutaneous injection

Further information

Yes

Trial or other data

May 21S-LITE RCT (n=195) found combination of a moderate-to-vigorous–intensity exercise program and liraglutide treatment after diet-induced weight loss was more effective in improving healthy weight loss than exercise alone, at 1 year follow-up [9].
Apr 20PIII study (NCT02918279; n=125) is published; it found liraglutide 3mg plus lifestyle therapy was superior to placebo plus lifestyle therapy, with regard to change from baseline in BMI standard-deviation score at week 56 (estimated difference, −0.22; 95% CI, −0.37 to −0.08; p=0.002) [6].
Aug 19PIII study (NCT02918279) completes [5].
May 19No results posted yet for PIII study (NCT02918279) [4].
Jul 18PIII study (NCT02918279) has completed recruitment and is due to complete collecting primary outcome data (change in BMI) in Feb 2019 [3].
Aug 16PIII trial to assess the efficacy of liraglutide SC injection for weight management in pubertal adolescent patients with obesity starts (NCT02918279). The 56-week, double-blind, randomised, parallel, placebo-controlled trial, followed by a 26-week period off study-drug, is designed to recruit 228 patients in the US, Belgium, Sweden, Mexico and Russia [2].

Evidence based evaluations

SaxendaPrader-Willi syndrome in children

Information

Saxenda
Licence extension / variation
Novo Nordisk
Novo Nordisk

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Glucagon-like peptide-1 (GLP-1) analogue
PWS is a rare genetic, neurodevelopmental syndrome characterized by hypothalamic-pituitary dysfunction with severe hypotonia and feeding deficits during the neonatal period followed by an excessive weight gain period with hyperphagia with a risk of severe obesity during childhood and adulthood, learning difficulties, deficits of social skills and behavioral problems or severe psychiatric problems. Prevalence at birth is estimated at 1 per 15,000-30,000 worldwide [1].
Prader-Willi syndrome in children
Subcutaneous injection