The FDA announced Friday the approval of MannKind's inhaled insulin Afrezza to improve glycaemic control in adults with diabetes. The decision follows near unanimous backing of the therapy from an FDA advisory panel in April. The regulator previously declined to approve the therapy in 2010 and 2011 after MannKind decided to switch inhalers during the review process.
The FDA said that the approval was based on data from clinical trials involving a total of 3017 patients with type 1 or 2 diabetes. The agency noted that among patients with type 1 diabetes, Afrezza was non-inferior to mealtime insulin aspart, both in combination with basal insulin, in reducing HbA1c levels at 24 weeks, while the therapy in combination with oral antidiabetic drugs was linked to a significantly greater reduction in HbA1c levels than placebo.
The US regulator indicated that Afrezza, which was approved with a risk evaluation and mitigation strategy, will carry a boxed warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease. Meanwhile, Griffin Securities analyst Keith Markey, who described the approval as "good news," asserted that the boxed warning from the FDA was "a non-event," adding "MannKind never wanted to market it to people with COPD."
For related analysis, see ViewPoints: Shake-up or false dawns? - biosimilar Lantus and inhaled insulin Afrezza approved and ViewPoints: Marketing strategy remains the key unknown as MannKind's inhaled insulin nears PDUFA date. See also Physician Views Poll Results – In for the long haul; post-marketing safety data will be key to driving uptake of inhaled insulin.
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