http://type2diabetestreatment.net/diabetes-type-2/injection-free-glp-1-receptor-agonist-for-t2d-under-fda-review/
Lea Eslava-Kim, PharmD February 08, 2017 Injection-Free GLP-1 Receptor Agonist for T2D Under FDA Review This article originally appeared on MPR. Share this content:
The NDA filed wtih the FDA was supported by data from the "ITCA 650 FREEDOM" phase 3 clinical trial.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ITCA 650 (Intarcia Therapeutics) for the treatment of type 2 diabetes (T2D). ITCA 650 continuously delivers exenatide via an osmotic mini-pump inserted subcutaneously into the abdominal wall.
The NDA was submitted on November 20, 2016, which was supported by data from a recently completed phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT01455857). Exenatide, the active ingredient in ITCA 650, is currently marketed as a twice-daily and once-weekly self-injection.
If approved, ITCA 650 would become the only twice-yearly, injection-free glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of T2D.
Continue Reading Below
ITCA 650 is designed to provide a continuous subcutaneous delivery of exenatide through Intarcia"s innovative technology platform, the Medici Drug Delivery System. Exenatide is continuously and consistently delivered via an osmotic mini-pump placed just beneath a patient"s skin in the abdomen.
A 3-month initiation dose, followed by consecutive 6-month maintenance doses are delivered, translating to twice-yearly dosing after initiation.
Related Articles- Risk for Cardiovascular Disease Not Significantly Different With GLP-1 Agonists
- Meta-Analysis Compares Cardiometabolic Effects, Safety of Once-Weekly GLP-1 Receptor Agonists
Reference
Intarcia Announces FDA Filing Acceptance of New Drug Application (NDA) for ITCA 650 for the Treatment of Type 2 Diabetes [news release]. Boston, MA: Intarcia Therapeutics, Inc.; February 3, 2017. http://www.prnewswire.com/news-releases/intarcia-announces-fda-filing-acceptance-of-new-drug-application-nda-for-itca-650-for-the-treatment-of-type-2-diabetes-300402157.html. Accessed February 7, 2017.
Loading links.... Related Topics- Type 2 Diabetes
Endocrinology Advisor Articles
- Polycystic Ovary Syndrome and Increased Risk for Disordered Eating
- AHA Scientific Statement: Effects of Meal Timing on CV Health
- High-Intensity Statin Therapy and Vitamin D Supplementation in Coronary Artery Disease
- Uncertainty in Medicine: An Endocrinologist"s Perspective
- The Handoff: Your Week in Endocrinology News - 2/3/17
- ADA Releases 2017 Standards of Medical Care in Diabetes
- Harmonized Testosterone Reference Ranges Established for Men
- Culture of Medical Training and Student Well-Being
- AHA Scientific Statement: Effects of Meal Timing on CV Health
- Type 1 Diabetes Associated With Gut Inflammation
- Continuous Glucose Monitoring Beneficial in Insulin-Treated Type 1 Diabetes
- Glycemic Response Independent of Initial Diabetic Medication in HIV-Infected Patients With T2D
- New Or Rapidly Deteriorating Type 2 Diabetes May Be Indicative of Pancreatic Cancer
- Injection-Free GLP-1 Receptor Agonist for T2D Under FDA Review
- HbA1c May Underestimate Glycemic Control in Blacks With Sickle Cell Trait
Sign Up for Free e-Newsletters
Type 2 Diabetes TreatingRenal Diabetic Diet
Advanced Diabetic Solutions
Original Article
#Diabetes_Type_2
#obesity_help
No comments:
Post a Comment