Drugs / Insulin Human [rDNA Origin]
Insulin Human [rDNA Origin]
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not stated1 trial | ||||||
| — | NCT01798914 | Oct 2008 → Apr 2015 | type 1 diabetes mellitus, type 2 diabetes mellitus | Mannkind Corporation | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT00359801 Comparator | Jul 2006 → Dec 2008 | diabetes mellitus | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2017-10-30 | Mannkind Corporation | Results Type 1 Diabetes Patients Using AFREZZA Have More Positive View of Therapy Compared to Standard Insulin Therapy mannkindcorp.com ↗
Results of a new patient-reported outcomes (PRO) study show that patients with type 1 diabetes who received the investigational ultra rapid acting mealtime insulin, AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, came to view insulin therapy more positively during the course of a 16-week study compared with patients using standard therapy insulin lispro, a rapid acting insulin, combined with basal insulin. |
| 2017-10-30 | Mannkind Corporation | Results Study Shows AFREZZA(R) Controls Blood Sugar Levels in Type 1 Diabetes, Results in Weight Loss, Less Hypoglycemia Than Usual Care mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results Study Shows AFRESA(R) Provides Rapid Suppression of Endogenous Glucose Production in Diabetes Patients mannkindcorp.com ↗
Results from the open-label, single-dose, three-way crossover study showed that endogenous glucose production (EGP) was suppressed earlier following AFRESA administration compared with subcutaneous insulin lispro and inhaled Exubera in adult patients with type 2 diabetes. |
| 2017-10-30 | Mannkind Corporation | Results Studies Show No Increased Risk of Cardiac Events in Diabetes Patients Treated with AFREZZA(R) mannkindcorp.com ↗
The findings of two separate studies further substantiate that treatment with the investigational ultra rapid acting mealtime insulin AFREZZA® (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events in type 1 or type 2 diabetes patients. |
| 2017-10-30 | Mannkind Corporation | Results Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients mannkindcorp.com ↗
These results indicate that AFRESA may be a promising new therapy for patients with type 1 and type 2 diabetes, as it controls post meal-time glucose levels with the added benefits of less weight gain and lower risk of hypoglycemia. |
| 2017-10-30 | Mannkind Corporation | Results New Findings Show Bioequivalence, Ease-of-Use and Efficiency of MannKind's Drug Delivery Platform mannkindcorp.com ↗
An additional study also demonstrated the bioequivalence of the Gen2 device and the clinical inhaler. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Updates Status of New Drug Application for AFREZZA(R) mannkindcorp.com ↗
The FDA stated that it will require approximately four additional weeks to complete its review of the NDA. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Updates Status of New Drug Application mannkindcorp.com ↗
The FDA explained that it has not yet completed its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes mannkindcorp.com ↗ |
| 2017-10-30 | Mannkind Corporation | Results MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that AFREZZA produces A1c reductions comparable to insulin aspart, |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R) mannkindcorp.com ↗
A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Announces Tentative Date of FDA Advisory Committee Review of AFREZZA mannkindcorp.com ↗
The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Announces Positive Clinical Data for AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints mannkindcorp.com ↗
We are pleased that both Phase 3 studies met their primary efficacy endpoints and that Study 171 also achieved its other main objective of demonstrating comparability between the Gen2 and MedTone inhalers, |
| 2017-10-30 | Mannkind Corporation | Regulatory MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. |
| 2017-10-30 | Mannkind Corporation | Results Follow-up Safety Data Show AFREZZA(R) Comparable to Standard Antidiabetic Therapy in Lung Function Tests mannkindcorp.com ↗
There was also no statistical difference in FEV1 between the treatment groups when examining subjects with Type 1 and Type 2 diabetes (p=0.6158 and p=0.1795, respectively). |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind mannkindcorp.com ↗
The letter cited no safety concerns, but requested updated safety data related to AFREZZA. |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind Corporation's Investigational Drug to Treat Diabetes mannkindcorp.com ↗
The FDA is not bound by the Advisory Committee's recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for AFREZZA. |
| 2017-10-30 | Mannkind Corporation | Regulatory FDA Accepts AFREZZA Complete Response Resubmission and Sets Target Action Date mannkindcorp.com ↗
In July 2010, the FDA accepted MannKind's reply to the Complete Response letter and set a PDUFA action date of December 29, 2010. |
| 2017-10-30 | Mannkind Corporation | Results CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
In addition, the changes in pulmonary function observed in the AFREZZA-Gen2 group were no different than those observed in an AFREZZA treatment group that utilized MannKind's first-generation (MedTone) inhaler. |
| 2017-10-30 | Mannkind Corporation | Results American Diabetes Association/The Lancet Symposium Will Highlight Study Showing AFREZZA(R) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care mannkindcorp.com ↗
Our findings show that mealtime AFREZZA, in combination with once-daily injected glargine, provides equivalent glucose control with fewer injections, less hypoglycemia and less weight gain than does twice-a-day, premixed insulin. |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA(R) Suppresses Endogenous Glucose Production More Rapidly Than Currently Available Insulin Therapy mannkindcorp.com ↗
AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, provides more rapid suppression of endogenous glucose production (EGP) after a meal than the subcutaneously-injected insulin lispro in patients with Type 2 diabetes, according to data presented today at the American Diabetes Association's 70th Scientific Sessions. |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA® Demonstrates Long-Term Efficacy in Controlling Blood Sugar Levels in Patients with Type 2 Diabetes mannkindcorp.com ↗
A reduction in severe hypoglycemic event rates was also observed (0.53 per 100 subject-months for patients treated with AFREZZA versus 1.17 per 100 subject-months for usual care subjects, p=0.67). |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA Demonstrates Non-Inferiority Compared to Standard Therapy in Controlling Blood Sugar Levels in Type 1 Diabetes Patients mannkindcorp.com ↗
In addition, patients treated with AFREZZA had significantly lower rates of total and mild/moderate hypoglycemia (6.2 versus 8.2 events per subject month [p=0.0345] and 6.0 versus 8.0 events per subject month [p=0.0269], respectively). |
| 2017-10-30 | Mannkind Corporation | Results AFRESA(R) Phase 3 Data Show Sustained Glycemic Control, Normal Lung Function in Patients over Four Years of Treatment mannkindcorp.com ↗
Results from the open-label, controlled study conducted with patients who had previously completed two three-month, randomized phase 2 clinical trials showed minimal mean change in forced expiratory volume in one second (FEV1) over a four-year period for those treated with AFRESA. |
All press releases naming this drug 27 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Insulin Human [rDNA Origin] | “Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder” NCT01798914 ↗ |
| Known as | EXU | “aiming to evaluate long-term pulmonary and cardiovascular safety of Exubera® (EXU; insulin human [rDNA origin] Inhalation Powder) in routine clinical practice.” PMID 32478195 ↗ Aug 2019 |
| Known as | Exubera | “aiming to evaluate long-term pulmonary and cardiovascular safety of Exubera® (EXU; insulin human [rDNA origin] Inhalation Powder) in routine clinical practice.” PMID 32478195 ↗ Aug 2019 |
| Route | Inhaled | “Inhalation Powder” NCT01798914 ↗ |