Victoza victory: drug beats Lyxumia in head-to-head

Novo Nordisk’s decision to pit its diabetes drug Victoza against rival Lyxumia from Sanofi in a head-to-head trial was a gamble that seems to have paid off.

The Danish drugmaker has just reported the results of the trial at the European Association for the Study of Diabetes (EASD) in Stockholm, Sweden, and concluded that Victoza (liraglutide) is significantly better than its rival at keeping blood sugar levels under control in patients with type 2 diabetes.

Victoza is already the top-selling drug in the glucagon-like peptide-1 (GLP-1) agonist class, and look set to consolidate that position if the new data stand up to scrutiny.

The LIRA-LIXI trial compared the efficacy and safety of Victoza versus Lyxumia, both given once-daily as an add-on to metformin, in 404 people with type 2 diabetes. Patients treated with Novo’s drug achieved a significantly larger reduction in haemoglobin A1c levels – which give an indicator of glucose control over time – compared to those on Sanofi’s drug.

In addition, around three quarters of people on Victoza achieved the treatment target of a 7 percent reduction in HbA1c, compared to 45 percent of the Lyxumia group, and the drug was also better at reducing fasting plasma glucose levels.

For Sanofi, the data is a setback as it gears up for a long-delayed approval for Lyxumia (lixisenatide) in the US, where it was rejected by the FDA in 2013 with a request for more data on its cardiovascular safety.

The drug was approved in Europe that same year and is also available in a number of other world market, but has struggled to make headway in the market with sales of just €18 million ($20m) in the first half of the year. It is due to be refiled in the US shortly.

In comparison, Victoza has around 75 percent market share among GLP-1 agonists and brought in 8.44bn Danish kroner ($1.28bn) in the first half.

The drug is facing additional competition from Eli Lilly and Boehringer Ingelheim’s once-weekly GLP-1 agonist Trulicity (dulaglutide), although Novo has its own once-weekly injectable semaglutide – also in testing as an oral therapy – in late-stage development.

The study comes alongside a battery of other studies at EASD supporting Novo drugs in a face-off with Sanofi in the diabetes market. Among these was a trial showing that a concentrated dose of the latter’s basal insulin candidate Tresiba (insulin degludec) is more effective than Sanofi’s blockbuster Lantus (insulin glargine) at controlling blood sugar and was less likely to cause hypoglycaemia.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.