The diabetes drug Suliqua has been approved for use in a wider range of people in the US.
The US Food and Drugs Administration expanded its indication for the drug on Wednesday 27 February.
Suliqua, developed by Sanofi, is a drug that contains two diabetes medicines: insulin glargine and lixisenatide. Insulin glargine is marketed as Lantus; lixisenatide is marketed as Adlyxin in the US and as Lyxumia in the UK.
The insulin and GLP-1 combination medication was approved by the European Union for treating type 2 diabetes in 2017.
The once-daily injectable drug had previously been approved in the US for use in people who were already taking either long-acting insulin or lixisenatide. The indication has now been widened to include people with type 2 diabetes who are struggling to control blood glucose levels on diet and exercise alone.
Michelle Carnahan, North America head of primary care for Sanofi which makes the drug, said: “This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals.”
The FDAs decision was based on the findings which showed people who were given Suliqua experienced greater reductions in blood glucose levels compared with those who took just Lantus or Adlyxin. The results from the LixiLan-O clinical trial were taken from 30 weeks of participants taking the drugs.
Suliqua’s side effects have been reported to include hypoglycemia, nausea, headache, stuffy or runny nose and sore throat, allergic reactions, diarrhoea and upper respiratory tract infection.
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