Dupixent Shows Superior Results vs Competition, Expands to New Treatment Areas

Rhea-AI Filing Summary

Sanofi has reported three significant developments in their drug portfolio through Form 6-K filed on June 28, 2025:

• Dupixent superiority demonstrated over Xolair (omalizumab) in the first-ever phase 4 head-to-head respiratory study for treating chronic rhinosinusitis with nasal polyps in patients with coexisting asthma (June 15, 2025)
• FDA approval secured for Dupixent as the only targeted medicine for treating bullous pemphigoid, expanding its therapeutic applications (June 20, 2025)
• CHMP recommendation received for Sarclisa's EU approval to treat transplant-eligible newly diagnosed multiple myeloma (June 23, 2025)

These developments represent significant regulatory and clinical milestones for Sanofi's key drug products, particularly strengthening Dupixent's market position across multiple indications and advancing Sarclisa's potential availability in the EU market for multiple myeloma treatment.

Positive

• Dupixent demonstrated superior efficacy over competitor Xolair in treating chronic rhinosinusitis with nasal polyps in patients with coexisting asthma, strengthening its competitive position
• Dupixent received FDA approval for bullous pemphigoid treatment, becoming the first and only targeted medicine for this indication, expanding its market potential
• Sarclisa received CHMP recommendation for EU approval in transplant-eligible newly diagnosed multiple myeloma, signaling likely expansion into first-line treatment setting

Negative

• None.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

 

For the month of June 2025

Commission File Number: 001-31368

SANOFI

(Translation of registrant’s name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒   Form 40-F ☐

 

1

In June 2025, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2 and 99.3 which are incorporated herein by reference.

Exhibit Index

 

Exhibit No.	  	Description        
Exhibit 99.1	  	Press Release dated June  15, 2025: EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study
Exhibit 99.2	  	Press Release dated June 20, 2025: Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
Exhibit 99.3	  	Press Release dated June 23, 2025: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma

 

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Dated: June 24, 2025	 		 		 	SANOFI
	 		 	By	 	/s/ Alexandra Roger
	 		 		 	Name: Alexandra Roger
	 		 		 	Title: Head of Legal Corporate & Finance

 

3

FAQ

What new drug approvals did SNY receive in June 2025?

In June 2025, Sanofi received two significant regulatory milestones: Dupixent was approved in the US for treating bullous pemphigoid, becoming the only targeted medicine for this condition. Additionally, Sarclisa received CHMP recommendation for EU approval to treat transplant-eligible newly diagnosed multiple myeloma.

How did SNY's Dupixent perform against Xolair in the Phase 4 trial?

According to the June 15, 2025 press release, Dupixent demonstrated superiority over Xolair (omalizumab) in a first-ever head-to-head respiratory study for treating chronic rhinosinusitis with nasal polyps in patients with coexisting asthma.

What new indications is SNY pursuing for Dupixent in 2025?

As of June 2025, Sanofi expanded Dupixent's indications with US FDA approval for bullous pemphigoid, making it the only targeted medicine approved for this condition. The drug also showed superior results in treating chronic rhinosinusitis with nasal polyps in patients with coexisting asthma.

What progress has SNY made in multiple myeloma treatment?

In June 2025, Sanofi's Sarclisa received a positive recommendation from the CHMP for EU approval to treat transplant-eligible newly diagnosed multiple myeloma. This represents a significant advancement in Sanofi's oncology portfolio.