MannKind Corporation has met the primary endpoints of its final two pivotal phase-3 studies of Afresa, the company's ultra rapid acting, inhaled insulin product. The company expects to disclose more details of the top-line data from these studies in patients with type-1 and type-2 diabetes (studies 030 and 102) by mid-December.
"We are very pleased to announce the positive outcome of these, the last of our three pivotal phase-3 studies. We look forward to presenting more complete data, including analyses of secondary endpoints, as soon as they are available, which are expected before the end of this year. Afresa promises to be an important additional option for the treatment of patients with diabetes. Our next step is to finalize a new drug application for Afresa, which we expect to submit to the FDA in early 2009," commented Dr Peter Richardson, MannKind's chief scientific officer.
MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer.