A federal court has extended pretrial deadlines in a wrongful death lawsuit alleging that the blockbuster drug Dupixent caused fatal lymphoma, giving manufacturers Sanofi and Regeneron additional time to respond as scrutiny around the medication intensifies.
The extension comes amid growing litigation involving Dupixent (dupilumab), an injectable biologic widely prescribed for eczema, asthma, and other inflammatory conditions. Plaintiffs in the emerging cases claim the companies failed to adequately warn patients and physicians about a potential lymphoma risk associated with long-term use.
The deadline extension is procedural, but it arrives at a pivotal moment for Dupixent, as regulators in Europe simultaneously move toward expanding the drug’s approved uses.
What the Court’s Deadline Extension Means
According to court filings, the judge overseeing the wrongful death case granted Sanofi and Regeneron until January 7, 2026, to formally respond to the complaint. The lawsuit alleges that Dupixent contributed to the development of lymphoma, ultimately leading to the patient’s death.
Deadline extensions are common in complex pharmaceutical liability cases, particularly when defendants are coordinating responses across multiple jurisdictions or anticipating broader litigation. Legal experts note that such extensions do not reflect the strength or weakness of the claims, but they often signal that parties are preparing detailed defenses.
This case is one of several lawsuits now forming the early stages of broader Dupixent-related litigation, with plaintiffs raising concerns about cancer risks, immune system effects, and delayed warnings.
Dupixent’s Expanding Use Raises New Questions
Dupixent is a monoclonal antibody that targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which play a central role in type 2 inflammation. Since its launch, the drug has been approved for multiple conditions, including:
- Atopic dermatitis (eczema)
- Moderate to severe asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Chronic spontaneous urticaria
In December 2025, the FDA approved a label update acknowledging a potential association between Dupixent and meningioma risk in certain patient populations, following reports and internal reviews. Plaintiffs argue this update came too late for patients who were exposed for years without adequate warning.
New NICE Guidance Expands Dupixent Use for COPD
On January 26, 2026, the UK’s National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending dupilumab for eligible adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils.
If finalized, the decision would make Dupixent the first NHS-reimbursed biologic therapy for COPD in England and Wales, with availability expected within 60 to 90 days depending on region.
The recommendation follows marketing authorization granted in September 2024, based on results from two large Phase 3 trials, BOREAS and NOTUS, which evaluated Dupixent as an add-on therapy for patients already using inhaled treatments.
Sanofi and Regeneron welcomed the announcement, calling it a major milestone for COPD treatment after years of limited innovation.
Why the Regulatory Win Matters to the Lawsuit
While the NICE guidance highlights Dupixent’s therapeutic potential, legal analysts say it may also intensify scrutiny surrounding safety disclosures.
Expanding approval means:
- Expanding approval means:
- More patients exposed for longer periods
- Increased off-label and long-term use
- Greater emphasis on post-marketing safety monitoring
Plaintiffs in the wrongful death and lymphoma cases argue that broader use heightens the responsibility to clearly warn about potential immune-related cancer risks, particularly when patients are immunomodulated for years.
Importantly, the NICE guidance does not address lymphoma risk directly, nor does it resolve allegations raised in U.S. courts.
What Plaintiffs Are Alleging
In the wrongful death lawsuit, the family alleges that:
- Dupixent altered immune system function in a way that increased lymphoma risk
- Sanofi and Regeneron knew or should have known of the risk earlier
- Warnings were delayed or insufficient for patients and physicians
- Earlier disclosure could have changed treatment decisions
Sanofi and Regeneron deny the allegations and maintain that Dupixent’s benefits outweigh its risks when used as directed.
No court has ruled on liability.
Where the Litigation Stands Now
The Dupixent wrongful death case remains in its early stages. The extended deadline allows defendants to submit formal responses, after which the court may address motions to dismiss, discovery schedules, or consolidation with other cases if additional lawsuits are filed.
Attorneys following the litigation say the coming months will be critical in determining whether Dupixent cases evolve into coordinated proceedings, similar to other biologic drug litigations.
For patients and families seeking more information, ongoing updates are being tracked on the Dupixent lawsuit page, which outlines eligibility, legal claims, and the latest court developments.
Why This Story Is Still Developing
The juxtaposition of expanding regulatory approval and active wrongful death litigation underscores a recurring tension in pharmaceutical oversight: drugs can deliver meaningful benefits while still carrying serious risks for certain patients.
As Dupixent moves toward becoming a standard-of-care biologic for additional conditions, courts will continue examining whether safety information kept pace with its rapid growth.
For now, the deadline extension signals that the legal fight over Dupixent’s alleged cancer risks is far from over and may only be beginning.
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