Inhaled Insulin Afrezza Denied Approval by FDA

In a major setback for MannKind Corporation’s inhalable insulin therapy, Afrezza, the FDA is requiring the company to conduct two additional clinical trials of the second-generation inhaler, one in type 1 diabetes and one in type 2 diabetes. Afrezza is an ultra rapid-acting mealtime insulin that is inhaled through a small inhalation device (fits in the palm of a hand). MannKind originally conducted large-scale studies using a first-generation “MedTone” device, but it is now applying for approval of Afrezza with a second-generation inhalation device, dubbed “Dreamboat,” that wasn’t tested in late-stage trials. The FDA’s requests suggest that the agency was not comfortable with the data submitted to show that the devices were equivalent. Interestingly, two ongoing trials of Afrezza in fact closely resemble the studies requested by the FDA. MannKind’s current strategy is to meet with the FDA to determine how the company can best move forward (and if the ongoing studies can be modified to satisfy the agency’s requests). While we had predicted that Afrezza could be in doctors’ offices as early as 2011 if approved, given this recent delay, we now believe that Afrezza could be available in late 2012. We caution that this assumes timely and productive meetings with the FDA as well as positive results from the additional clinical trials. We will be following Afrezza for any updates, and we especially look forward to hearing the outcome of the company’s upcoming meeting with the FDA. --ST