French pharma company Sanofi received good news this week with separate European approvals for drugs to treat diabetes and cancer.
The European Commission (EC) granted marketing authorisation to Lyxumia for use in adults with type 2 diabetes to achieve glycaemic control in combination with other treatments, while Zaltrap was approved for use in the treatment of previously treated metastatic colorectal cancer (mCRC).
Lyxumia (lixisenatide), 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 for Sanofi, with the company putting a lot of resources into expanding its diabetes activities in recent years.
This includes its huge-selling basal insulin Lantus, which Lyxumia is able to complement as an add-on therapy.
The approval is based on data from the GetGoal clinical programme, which demonstrated that Lyxumia was able to reduce blood sugar levels and has a beneficial effect on body weight in patients with type 2 diabetes, with only a limited risk of hypoglycaemia.
Speaking to PMLiVE, Bo Ahren, professor at the faculty of medicine, Lund University, Sweden, described how the drug works by simulating GLP-1 – a naturally-occurring peptide hormone that is released in a person’s body following a meal.
This hormone can help people with diabetes by suppressing the secretion of glucagon (a hormone to raise glucose levels) from the pancreas and stimulating its secretion of insulin (a hormone to reduce blood glucose levels).
Prof Ahren also explained the need for extra treatments to help control people’s blood sugar levels, noting that some studies in several European countries have demonstrated that up to 50 per cent of people with type 2 diabetes are unable to reach HbA1c targets
“That could be for several reasons,” said Prof Ahren “like the insulin causes hypoglycaemia so that the patient cannot increase the dose.”
It’s for these insulin-using patients that Lyxumia has its maximum benefit, according to Prof Ahren, being able to help control glucose without increasing the risk of hypoglycaemia.
He said: “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. So to have a treatment with very low risk is a real advantage.”
In addition to its benefits in not increasing the risk of hypoglycaemia, Prof Ahren also noted Lyxumia’s ability to reduce body weight by affecting brain function to induce satiety.
“GLP-1s are actually the first class of therapy we have that has those two effects,” he said.
Lyxumia’s approval is good news too for the drug’s inventors Zealand Pharma who signed a deal with Sanofi to further develop the drug.
Although there is no specific milestone payment associated with European approval, the company is entitled to royalties on global net sales of Lyxumia and combination products.
Zealand also said it is eligible to receive remaining development, regulatory and sales milestone payments of up to $215m.
Zaltrap gets colorectal cancer approval
Meanwhile, Sanofi’s Zaltrap (aflibercept) has been approved by the EC in combination with FOLFIRI chemotherapy to treat adults with mCRC that is resistant to or has progressed after previous treatment with a regimen including oxaliplatin (marketed by Sanofi as Eloxatin).
The approval comes the day after World Cancer Day and offers another treatment option for what is the second leading cause of cancer death in Europe.
Zaltrap was developed in partnership with Regeneron, and is already available as a treatment for the eye condition age-related macular degeneration (AMD) under the name Eylea.
However, it has demonstrated its positive effect in oncology, with studies showing it is able to improve both overall survival (median from 12.06 months to 13.50 months) and progression-free survival (4.67 months to 6.90 months) in patients with mCRC.
The drug is already available in the US under the mCRC indication following FDA approval in August, 2012.