AfrezzaTreatment for Diabetes Type 1, Diabetes Type 2
Update: Afrezza (insulin human) Now FDA Approved - June 27, 2014
MannKind Updates Status of New Drug Application for Afrezza
VALENCIA, Calif., April 7, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Afrezza® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.
Afrezza® (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of Afrezza Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, AFREZZA®, is under review by the FDA. MannKind regularly posts copies of its press releases as well as additional information about MannKind on its website www.mannkindcorp.com. Interested persons can subscribe on the website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
Source: MannKind Corporation
Posted: April 2014
- FDA Approves Afrezza to Treat Diabetes - June 27, 2014
- FDA Advisory Committee Recommends Approval of Afrezza - Investigational Drug to Treat Diabetes - April 2, 2014
- MannKind Resubmits New Drug Application to U.S. FDA for Afrezza for the Treatment of Adults with Diabetes - October 14, 2013
- MannKind Reports Positive Data from a Phase 3 Clinical Study of Afrezza in Patients with Type 1 Diabetes - August 14, 2013
- MannKind Confirms Design of Pivotal Studies for Afrezza - August 12, 2011
- MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza - January 20, 2011
- MannKind Updates Status of New Drug Application for Afrezza - December 28, 2010
- FDA Accepts Afrezza Complete Response Resubmission and Sets Target Action Date - July 20, 2010
- FDA Requests Additional Information Regarding Afrezza in Complete Response Letter to MannKind - March 15, 2010
- MannKind Updates Status of Afrezza New Drug Application - January 13, 2010
- Emisphere Technologies Receives Milestone Payment from MannKind Corporation - May 21, 2009
- MannKind Submits NDA for Afresa for Treatment of Diabetes - March 16, 2009