New insulin scores for Sanofi
pharmafile | December 5, 2013 | News story | Research and Development, Sales and Marketing | Lantus, Sanofi, diabetes, u300
Sanofi has been cheered after late-stage results from its investigational insulin U300 showed that the product may have advantages over its blockbuster brand Lantus.
In the EDITION II trial it demonstrated similar blood sugar control, with 23% fewer patients experiencing night-time low blood sugar compared with Lantus (insulin glargine injection), the company says.
Patients had type 2 diabetes and were already using basal insulin with mealtime insulin or oral medication. The data, presented at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, suggests that the product may have a big future.
“We are encouraged by these results which suggest that U300 could be a viable treatment option for a wide range of people with type 1 and type 2 diabetes,” said Pierre Chancel, Sanofi’s senior vice president, global diabetes.
A replacement for Lantus, a multi-billion dollar seller for Sanofi, would be welcome. Competition exists, with Mylan having rights to develop and market Biocon’s biosimilar version of the drug, called Glargine, for example.
U300 itself is a new formulation based on Lantus’ glargine molecule, but Sanofi says it offers the benefit of a smaller subcutaneous injection compared with Lantus.
EDITION II met its primary endpoint with similar reductions in HbA1c from baseline between U300 and Lantus at six months. Meanwhile the percentage of patients with severe or confirmed nocturnal hypoglycemia from month three to six was 21.6% (U300) versus 27.9% (Lantus).
Over the six-month treatment period, the incidence of any nocturnal hypoglycemia at all was also lower with U300 than with Lantus (30.5% as against 41.6%) – so too the percentage of patients suffering any hypoglycemic event at any time of the day over a 24-hour period (U300: 71.5% and Lantus: 79.3 per cent).
That result was also found across the whole of the six-month study period, including the first eight weeks of the trial.
“Reducing the risk of hypoglycemic events is imperative for effective management of diabetes, and EDITION II suggests that U300 reduces the risk of these events, even in a challenging patient population who have been on high basal insulin doses and oral medications without being able to achieve their treatment targets,” said Hannele Yki-Järvinen, professor of medicine at the University of Helsinki.
Top-line results from the EDITION III study, which compared U300 with Lantus in 878 people with type 2 diabetes who had not previously been treated with insulin and uncontrolled on oral medication, found the primary endpoint – similar blood sugar level control, measured by HbA1c, from baseline to month six – was also met.
Adam Hill
Related Content
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition
The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) …
Sanofi completes acquisition of Vigil Neuroscience to early neurology pipeline
Sanofi has announced that it has finalised its acquisition of Vigil Neuroscience, a US-based biotechnology …
