Saxenda
Metabolic· 1994 cited findings· 3 source documents
Company: Novo Nordisk A S →
What the regulatory reviews say
Saxenda (liraglutide) is a drug reviewed under Application Number 206321 (NDA SE8) with a PDUFA Goal Date of April 27, 2017. The regulatory submission date was June 24, 2016. The clinical development program for liraglutide weight management included 5813 subjects.
In terms of efficacy, 56% of patients in the Saxenda arm lost >=5% body weight, compared to 25% in the placebo arm. The mean change in body weight was -4.8% for Saxenda, while the placebo arm showed a 2.6% mean change. The treatment difference in mean change in body weight was -2.2%. Regarding Type 2 Diabetes Mellitus (T2DM) diagnosis, 12.8% of the Saxenda arm received a T2DM diagnosis, compared to 6.2% in the placebo arm. Over a 160-week treatment phase, 26 patients developed T2DM in the Saxenda arm, versus 46 patients in the placebo arm.
Safety findings include an acute pancreatitis incidence of 0.3% and cholelithiasis adverse events at 2.2%. Cholecystitis incidence was 0.8%. Patients experienced a mean increase in resting heart rate of 2 to 3 bpm. Additionally, 34% of patients had a >10 bpm heart rate increase at two consecutive visits, and 5% had a >20 bpm heart rate increase at two consecutive visits.
Key figures — cited to the source page
| Patients losing >=5% body weight (Saxenda arm) | 56 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.41 |
| Patients losing >=5% body weight (placebo arm) | 25 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.41 |
| Mean change in body weight (Saxenda) | -4.8 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.71 |
| Mean change in body weight (placebo) | 2.6 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.71 |
| T2DM diagnosis (Saxenda arm) | 12.8 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.40 |
| T2DM diagnosis (placebo arm) | 6.2 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.40 |
| Acute pancreatitis incidence | 0.3 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.15 |
| Cholelithiasis adverse events | 2.2 | NOVO — Saxenda FDA Review (NDA/BLA 206321, 2019), p.15 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.