Navigation Links
MannKind Submits NDA for AFRESA for Treatment of Diabetes
Date:3/16/2009

VALENCIA, Calif., March 16 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of AFRESA(R) (insulin monomer human [rDNA origin]) Inhalation Powder and the AFRESA(R) Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.

There are 23.6 million people in the United States, or 8% of the population, who have diabetes. Diabetes currently affects 246 million people worldwide and is expected to affect 380 million by 2025. Each year, a further 7 million people develop diabetes and 3.8 million people succumb to the disease.

AFRESA is an ultra rapid-acting insulin. It is a drug-device combination product, consisting of AFRESA Inhalation Powder pre-metered into single unit dose cartridges and the AFRESA Inhaler as the delivery device for oral inhalation. However, the feature that distinguishes AFRESA from all other insulin products is not the route of administration - it is the pharmacokinetic profile. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive AFRESA particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream. AFRESA achieves peak insulin levels within 12-14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals, but which is absent or impaired in patients with diabetes.

The NDA submission is based on an extensive clinical program, involving 44 completed studies and five ongoing studies at the time of submission. The clinical program included over 5,300 patients. More than 2,450 subjects with type 1 or type 2 diabetes were randomly assig
'/>"/>

SOURCE MannKind Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. MannKind Agrees with Pfizer on the Purchase of Frankfurt Insulin Manufacturing Plant
2. MannKind Corporation to Hold Fourth Quarter Financial Results Conference Call on February 17, 2009
3. MannKind to Present at the 11th Annual Biotechnology Industry Organization BIO CEO & Investor Conference
4. SemBioSys receives US$2.5 million from option agreement with MannKind for plant-produced insulin
5. MannKind to Present at the Piper Jaffray 20th Annual Health Care Conference
6. MannKind to Present at the Rodman & Renshaw Annual Global Investment Conference
7. MannKind Corporation to Hold Third Quarter Financial Results Conference Call on November 5, 2008
8. MannKind Unveils Proposed Trade Name at Dedication of Danbury Manufacturing Facility
9. MannKind to Present at the UBS Global Life Sciences Conference
10. MannKind Corporation Reports Second Quarter Financial Results
11. MannKind Corporation to Hold Second Quarter Financial Results Conference Call on August 11, 2008
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2015)... ... , ... Strong Animals™ announced today that research conducted by South Dakota State ... ADSA-ASAS Joint Annual Meeting held July 12-16 in Orlando, FL showed feed additive Stay ... content. Also, feed containing Stay Strong™ for Dairy Cows took longer than 7.7 hours ...
(Date:7/28/2015)... 28, 2015 People with a common form ... significant and sometimes profound improvements in their hearing and ... to a new multicenter study led by specialists at ... described online ahead of print in the journal The Laryngoscope ... clinics in the United States ...
(Date:7/28/2015)... -- Research and Markets ( ... "Analysis of the Global Flow Cytometry Market ... Globally, flow cytometry remains a popular tool for ... stem cells. But the market is witnessing active ... from underdeveloped nations to quantitate CD4 cell markers ...
(Date:7/28/2015)... July 28, 2015 Deerfield Management Company, L.P. ... Fund, L.P., which will invest in groundbreaking advancements in ... diseases, cancer, and orphan diseases. The venture capital fund ... therapeutics are developed and improve the way healthcare is ... the largest healthcare-focused venture funds in the sector, will ...
Breaking Biology Technology:Strong Animals™ Announces South Dakota State University Research Demonstrates Stay Strong™ for Dairy Cows Improves Performance and Feed Stability 2Hybrid Cochlear Implants For Common Form Of Hearing Loss May Benefit Millions 2Hybrid Cochlear Implants For Common Form Of Hearing Loss May Benefit Millions 3Analysis of the Global Flow Cytometry Market 2012-2018 with a 2014 Base Year and a 2015-2018 Forecast Period 2Deerfield Launches $550 Million Healthcare Venture-Capital Fund 2Deerfield Launches $550 Million Healthcare Venture-Capital Fund 3
... Sept. 4, 2007 Computing researchers at Houston,s ... Technological University (NTU) today announced the formation of ... joint research initiative, valued at 4 million Singapore ... costs for embedded microchips -- special-purpose computer chips ...
... Sept. 4 ,Zimmer Holdings, Inc. (NYSE: ZMH ... and Tutogen Medical, Inc., a leading manufacturer of ... animal,(xenograft) tissue, today announced the expansion of Tutogen,s ... of Zimmer Holdings,Inc., into Europe, the Middle East ...
... Sept. 4 Beckman Coulter,Inc. (NYSE: BEC ... that simplify, automate, and innovate complex biomedical testing,announced ... chief,executive officer, will present at the 2007 Bear ... 11:00 a.m. (EDT). (Logo: http://www.newscom.com/cgi-bin/prnh/20031202/BECLOGO ) ...
Cached Biology Technology:Rice, Nanyang Tech collaborate on sustainable nanoelectronics 2Rice, Nanyang Tech collaborate on sustainable nanoelectronics 3Zimmer and Tutogen Announce Agreement for International Distribution of Biological Products 2Zimmer and Tutogen Announce Agreement for International Distribution of Biological Products 3Zimmer and Tutogen Announce Agreement for International Distribution of Biological Products 4Zimmer and Tutogen Announce Agreement for International Distribution of Biological Products 5Beckman Coulter to Present at the Bear Stearns Healthcare Conference 2
(Date:7/21/2015)... 2015 Passwords have proven futile for ... recent U.S. Office of Personnel Management breach. Biometric ... conundrum, but developers and end-users are concerned about ... dilemma, Biometrics-as-a-Service provider HYPR Corp. announced today the ... third party integration. A video ...
(Date:7/13/2015)... 13, 2015 Synaptics Inc. (NASDAQ: ... solutions, today announced sampling of ClearPad ® ... integration (TDDI) product targeting smartphones and tablets. This ... Synaptics , best-in-class touch controller IP and ... developed in the company,s Japan Design Center. TDDI ...
(Date:7/9/2015)... July 9, 2015  Synaptics Inc. (NASDAQ: SYNA ), ... that it will report financial results for the fourth ... 2015 after the close of market. The company will ... at 2:00 p.m. PT (5:00 p.m. ET), during which ... participate on the live call, analysts and investors should ...
Breaking Biology News(10 mins):HYPR Corp. Launches Industry First Biometric Tokenization Platform 2HYPR Corp. Launches Industry First Biometric Tokenization Platform 3HYPR Corp. Launches Industry First Biometric Tokenization Platform 4Synaptics Announces Sampling of Second Generation TDDI Solutions 2Synaptics Announces Sampling of Second Generation TDDI Solutions 3Synaptics to Report Fourth Quarter, Fiscal Year 2015 Results on July 30 2
... of stem cells that can repair the most severe damage ... reservists normally lie around and do nothing, but when neighboring ... action. A report on the discovery will appear online next ... like the Army Reserves of our nose,?explains lead author Randall ...
... - a synthetic designed to mimic fat - Salk Institute ... switch on PPAR-d, the master regulator that controls the ability ... are not active, turning on the chemical switch activates the ... in energy balance (calories in, calories burned) makes the mice ...
... are able to interpret the mental state of others ... a new University of Nottingham study has found. , ... autistic children can ‘read?a stranger’s mental state based on ... to be poor at interpreting people’s mental states based ...
Cached Biology News:When smell cells fail they call in stem cell reserves 2'Exercise pill' switches on gene that tells cells to burn fat 2'The eyes have it' -- Autism research yields surprising results 2