The European Medicines Agency has recommended the approval of two Sanofi drugs – one for diabetes and another for colorectal cancer.
The agency’s Committee for Medicinal Products for Human Use (CHMP) said in a statement that it had adopted a positive opinion on injectable drug Lyxumia for the treatment of type 2 diabetes in adults.
It said the main benefit of Lyxumia is its ability to improve glucose metabolism when added to an existing oral antidiabetic therapy and/or insulin.
The most common side effects of the once-daily GLP-1 receptor, which was developed by Danish firm Zealand Pharma and licensed to Sanofi, are nausea, vomiting and diarrhoea.
CHMP also recommended the granting of marketing authorisation of Zaltrap in combination with FOLFIRI chemotherapy for the treatment of adults with metastatic colon cancer.
Zaltrap acts as a decoy receptor of Vascular Endothelial Growth Factor (VEGF) thereby blocking the VEGF biological pathway, which is important to the blood supply of tumours.
The committee said the benefits of the drug are its ability to improve survival of patients and to delay the progression of disease compared to a placebo.
The US Food and Drug Administration approved the intravenous drug in August 2012 after it was accelerated for review four months earlier.
A Phase III trial compared chemotherapy regimen Folfiri in combination with either Zaltrap or a placebo in 1,226 patients whose cancer failed to respond to treatment with an oxaliplatin-containing regimen.
Results showed that patients taking Zaltrap with Folfiri increased their median survival from 12.06 months to 13.50 months and progression-free survival from 4.67 months to 6.9 months.
Image: Sanofi’s research centre in Strasbourg. Photo courtesy of Sanofi.
