US patients with diabetes can now get access to an inhaled form of insulin for the first time following the launch of Sanofi and Mannkind’s Afrezza.
Afrezza is a dry formulation of human insulin delivered through a small, discreet inhaler, which finally won US clearance in June last year to improve glycaemic control after its third shot at approval, albeit with a boxed warning that it should not be used in patients with chronic lung disease.
The US Food and Drug Administration also ordered four post-marketing studies - one in children, another to evaluate pulmonary and cardiovascular risks and two looking at how it works and dosage.
Sanofi bought rights to Afrezza from Mannkind in August last year in a deal worth up to $925 million.
According to Sanofi’s Pierre Chancel, senior vice president of its Diabetes Division, the drug is “an important addition to Sanofi’s growing diabetes portfolio of integrated, personalised offerings,” and he highlighted “the need for an insulin that doesn’t require an injection”.
However, some industry observers are still on the fence over whether an inhaled insulin product will make much of a splash in the market, particularly given that Pfizer’s version Exubera was pulled off pharmacy shelves years ago after failing to make any impact.