FDA Events for Sanofi (SNYNF)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Sanofi (SNYNF).
Over the past two years, Sanofi has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Dupixent. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Dupixent (dupilumab) - FDA Regulatory Timeline and Events
Dupixent (dupilumab) is a drug developed by Sanofi for the following indication: Moderate-to-severe asthma.
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:
- Dupixent (dupilumab)
- Announced Date:
- November 15, 2024
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.
AI Summary
Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has accepted for review the resubmitted Supplemental Biologics License Application (sBLA) for Dupixent (dupilumab). This application targets the treatment of chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older whose symptoms remain uncontrolled despite H1 antihistamine treatment.
The resubmission, backed by new pivotal data from the LIBERTY-CUPID Phase 3 clinical program, shows that Dupixent significantly reduces both itch and hive activity. This is a crucial development for the more than 300,000 CSU patients in the US who have limited treatment options. The FDA is expected to make a decision by April 18, 2025, and, if approved, Dupixent would be the first targeted therapy for CSU in a decade.
Read Announcement- Drug:
- Dupixent (dupilumab)
- Announced Date:
- November 15, 2024
- Estimated Event Date Range:
- April 18, 2025 - April 18, 2025
- Target Action Date:
- April 18, 2025
- Indication:
- Moderate-to-severe asthma
Announcement
Regeneron Pharmaceuticals, Inc announced that The target action date for the FDA decision is April 18, 2025.
AI Summary
Regeneron Pharmaceuticals announced a key milestone for Dupixent (dupilumab) as the FDA has set the target action date for its decision on the resubmitted supplemental biologics license application at April 18, 2025. This application focuses on the treatment of chronic spontaneous urticaria (CSU) in patients who do not achieve adequate control with H1 antihistamines. New pivotal data from the Phase 3 LIBERTY-CUPID clinical program showed that Dupixent significantly reduced both itch and hives in patients suffering from this condition. With over 300,000 Americans affected by CSU, the potential approval of Dupixent could offer a much-needed targeted therapy option. Regeneron’s positive developments reflect ongoing efforts to advance targeted therapies and improve patient care for those who have limited alternatives for managing CSU.
Read Announcement
Sanofi FDA Events - Frequently Asked Questions
As of now, Sanofi (SNYNF) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sanofi (SNYNF) has reported FDA regulatory activity for Dupixent (dupilumab).
The most recent FDA-related event for Sanofi occurred on November 15, 2024, involving Dupixent (dupilumab). The update was categorized as "FDA Accepted," with the company reporting: "Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment."
Currently, Sanofi has one therapy (Dupixent (dupilumab)) targeting the following condition: Moderate-to-severe asthma.
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 (OTCMKTS:SNYNF) was last updated on 7/12/2025 by MarketBeat.com Staff
