It was good news this week for Sanofi, as the French pharma company received separate European approvals for drugs to treat diabetes and cancer. The drug Lyxumia was granted marketing authorisation for use in adults with type 2 diabetes to achieve glycaemic control in combination with other treatments, while the European Commission (EC) also approved Zaltrap for use in the treatment of previously treated metastatic colorectal cancer (mCRC).
Sanofi has invested a lot of resources into expanding its diabetes activities in recent years, and so the news about Lyxumia – which is approved for use as a single daily injection alongside an oral glucose-lowering medicinal products and/or basal insulin in patients with inadequate glycaemic control – is especially important. Lyxumia is able to complement huge-selling basal insulin Lantus as an add-on therapy.
The GetGoal clinical programme is what clinched the approval for Sanofi, as it demonstrated the effectiveness of Lyxumia, as well as the drug’s limited risk of side effects. In patients with type 2 diabetes, Lyxumia was able to reduce blood sugar levels and had a beneficial effect on body weight, with only a narrow risk of hypoglycaemia. Bo Ahren, professor at the faculty of medicine, Lund University, Sweden, explained that the drug works by simulating your GLP-1 hormone, which your body usually releases following a meal. This hormone suppresses your glucagon secretion – and therefore your glucose levels – while stimulating your secretion of insulin (a hormone to reduce blood glucose levels).
Professor Ahren also clarified why there is a real need for extra treatments to help control people’s blood sugar levels. He noted some studies in several European countries, which have found that up to half of people with type 2 diabetes are unable to reach HbA1c targets. According to Professor Ahren, ‘That could be for several reasons; like the insulin causes hypoglycaemia so that the patient cannot increase the dose.’ He commented that Lyxumia has its maximum benefit for these insulin-using patients, as it helps them to control their glucose without increasing the risk of hypoglycaemia.
‘Severe hypoglycaemia can cause serve acute symptoms, and it has also been shown that repeated hypoglycaemia can cause negative effects on cardiovascular function so it can be a risk factor for heart disease,’ Professor Ahren warned. ‘So to have a treatment with very low risk is a real advantage.’ He added that Lyxumia’s ability to reduce body weight by affecting brain function to induce satiety is another plus point, noting, ‘GLP-1s are actually the first class of therapy we have that has those two effects.’