FDA Events for Insulet (PODD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Insulet (PODD).
Over the past two years, Insulet has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Omnipod. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Omnipod 5 - FDA Regulatory Timeline and Events
Omnipod 5 is a drug developed by Insulet for the following indication: Automated Insulin Delivery System for with type 1 diabetes (T1D).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Omnipod 5
- Announced Date:
- August 26, 2024
- Indication:
- Automated Insulin Delivery System for with type 1 diabetes (T1D)
Announcement
Insulet Corporation announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management.
AI Summary
Insulet Corporation has announced that its Omnipod 5 Automated Insulin Delivery System is now approved for use by people with type 2 diabetes aged 18 and older in the U.S. This milestone makes Omnipod 5 the first and only automated insulin delivery (AID) system that is FDA-cleared for managing both type 1 and type 2 diabetes. This groundbreaking approval opens new possibilities for approximately 6 million U.S. patients with insulin-requiring type 2 diabetes who can now benefit from its innovative, tubeless design and automated technology.
Designed to simplify diabetes management, the Omnipod 5 uses SmartAdjust™ technology to automatically adjust insulin delivery every five minutes. The system helps users achieve better glycemic control without the need for multiple daily injections, offering improved health outcomes and enhanced freedom for people managing their diabetes.
Read Announcement- Drug:
- Omnipod 5
- Announced Date:
- June 21, 2024
- Indication:
- Automated Insulin Delivery System for with type 1 diabetes (T1D)
Announcement
Insulet Corporation shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin.
AI Summary
Insulet Corporation recently presented positive findings at the ADA 84th Scientific Sessions in Orlando, Florida, from its Omnipod 5 Automated Insulin Delivery System type 2 diabetes pivotal trial. This landmark study, the largest and most racially diverse to date, involved people with type 2 diabetes who require insulin. The trial showed that using Omnipod 5 significantly improved blood sugar control by reducing HbA1c levels, lowering time in hyperglycemia, and increasing the period spent in the healthy target range without increasing hypoglycemia risk. Participants also experienced a reduction in the daily insulin dose and a meaningful decrease in diabetes distress. Insulet has submitted the trial results to the FDA in hopes of expanding Omnipod 5’s use for people with type 2 diabetes, aiming for a potential U.S. launch in early 2025.
Read Announcement
Insulet FDA Events - Frequently Asked Questions
As of now, Insulet (PODD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Insulet (PODD) has reported FDA regulatory activity for Omnipod 5.
The most recent FDA-related event for Insulet occurred on August 26, 2024, involving Omnipod 5. The update was categorized as "Provided Update," with the company reporting: "Insulet Corporation announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management."
Currently, Insulet has one therapy (Omnipod 5) targeting the following condition: Automated Insulin Delivery System for with type 1 diabetes (T1D).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PODD) was last updated on 7/13/2025 by MarketBeat.com Staff
