The device Afrezza will be distributed in
Sanofi has launched what will be the only inhaled insulin available to treat people with diabetes in the US.
The company is working with the drug’s inventor MannKind to bring the insulin – known as Afrezza – to people with both type 1 and type 2 diabetes in the US seven months after the drug was approved by the FDA.
The product is a drug-device combination consisting of a dry formulation of human insulin to be delivered from a small and portable inhaler, such as those that deliver asthma medication.
Afrezza is the only product of its kind available in the US and offers patients an alternative to current methods of insulin treatment, such as injections and pens.
As with existing insulin products Afrezza can be used to help control blood sugar as part of a wider diabetes management plan, including diet, exercise and other diabetes treatments.
Pierre Chancel, head of Sanofi’s diabetes division said: “There is a recognised need for an insulin that doesn’t require an injection, and our organisation is committed to making this new treatment option available to patients.”
The path to market has not been easy for Afrezza. MannKind had to wait until its third marketing application before receiving approval from the FDA, with the delays forcing the company to cut 41% of its workforce in 2011.
The regulator had concerns about the amount of data available on the drug regarding its efficacy in people with type 1 diabetes and its safety. However, these were addressed by MannKind in two phase III trials.
Shortly after winning FDA approval for Afrezza MannKind put its faith in the might of diabetes giant Sanofi to make an impact on the insulin market in the US by signing a $925m deal in August 2014.
Afrezza is now the first alternative to insulin injections since Pfizer’s ill-fated Exubera, which launched in 2006 but was withdrawn a year later due to lacklustre sales and concerns about the risk of dosing errors with the product’s inhaler device.
The problems faced by Pfizer also prompted Lilly/Alkermes and Novo Nordisk/Aradigm to discontinue their own programmes, despite reaching the phase III testing stage.