Drug developer MannKind Corp. said Thursday its fast-acting inhaled insulin Afresa met its goals in two clinical trials, as the drug was more effective in lowering blood sugar than other drugs and did not cause lung damage. Both late stage trials met their goals, the company said. The first showed that a combination of Afresa and long-acting insulin lowered blood sugar levels more than a premixed twice-per-day insulin injection. In the second trial, the company said no adverse effects on the lungs were observed. MannKind said it plans to request Food and Drug Administration approval of Afresa in early 2009. It will report full results from the two trials, called study 102 and study 030, in mid-December. More than 2,000 type 1 and type 2 diabetes patients were involved in the trials. Afresa is a powdered insulin that is designed to be inhaled and dissolve immediately on contact with the lungs, allowing the body to reach peak levels within 12 to 14 minutes. That’s similar to the way insulin is released in people without diabetes, MannKind said. By contrast, the company said injected insulin can take up to an hour to reach peak levels, and they can also take longer to return to normal levels. MannKind is developing drugs that can be inhaled and absorbed more easily with a technology called Technosphere.
