On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).  This follows the FDA’s May 2024 acceptance of the sBLA for Dupixent® for priority review for adolescents with CRSwNP.

On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent® grew by 29.2% to €3,303 million in the second quarter of 2024.  Sanofi expects the product to generate revenue of about €13 billion for 2024.

On 12 September 2024, Sanofi and Regeneron announced that Health Canada has approved Dupixent® (dupilumab) for the treatment of patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).  This approval expands the initial Health Canada approval for EoE in May 2023 for patients aged 12 years and older, weighing at least 40 kg.

Dupixent® has previously received FDA approval for these indications, being approved for paediatric patients aged 1 to 11 years (weighing at least 15 kg) with EOE in January 2024 and for EoE in patients 12 years and older in May 2022.

On 11 September 2024, Sanofi and Regeneron announced that a confirmatory phase 3 study of Dupixent® (dupilumab) met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.

The phase 3 data will be submitted by Sanofi and Regeneron to FDA by the end of 2024 to support the resubmission of their sBLA for Dupixent® for CSU.  This follows the FDA’s October 2023 Complete Response Letter requiring further efficacy data.

Japan was the first country in the world to approve Dupixent® for CSU in February 2024.

On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent (dupilumab) grew by 29.2% to €3,303 million in the second quarter of 2024.  Sanofi expects the product to generate revenue of about €13 billion for 2024. 

Earlier this month, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent for COPD anywhere in the world.  In May 2024, the FDA accepted Sanofi’s and Regeneron’s sBLA for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). 

On 17 July 2024, ASLAN Pharmaceuticals announced that it has filed for voluntary liquidation of its Singaporean sole operating subsidiary and will itself also apply for liquidation.  ASLAN reports that the appointed liquidator of the Singapore subsidiary will seek “potential strategic alternatives” for the company’s eblasakimab (a first-in-class monoclonal antibody) and farudodstat.

In April 2024, ASLAN had announced positive interim results from a Phase 2 Study (TREK-DX) of eblasakimab in moderate-to-severe atopic dermatitis adult patients previously treated with dupilumab.  ASLAN entered into an exclusive licence with Zenyaku Kogyo in June 2023 to develop and commercialise eblasakimab to treat atopic dermatitis in Japan.

On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.  This is the first approval of Dupixent for COPD anywhere in the world, and the sixth approved indication for the drug in the EU.   

Dupixent was recommended by the CHMP for COPD on 31 May 2024.  In February 2024, the FDA accepted Dupixent® for priority review for the same indication.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024.

On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD). 

This comes after the FDA accepted Dupixent® for priority review for the same indication in February 2024.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024. 

On 20 May 2024, Regeneron and Sanofi announced the results of the NOTUS Phase 3 trial for use of  Dupixent® (dupilumab) as a maintenance treatment in adults with uncontrolled COPD and type 2 inflammation. The results were published in the New England Journal of Medicine on 21 May 2024 and reportedly demonstrate that Dupixent reduced exacerbations by 34% and improved lung function compared to placebo.   Previously, on 13 May 2024, Regeneron and Sanofi announced that the FDA accepted for priority review their sBLA for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). 

On 13 May 2024, Regeneron and Sanofi announced that the FDA has accepted for priority review their supplemental biologics licence application (sBLA) for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).   The target action date for the FDA decision is 15 September 2024.  If the new indication is approved, it will be the first treatment in the US for adolescents with inadequately controlled CRSwNP.

This is the second sBLA for Dupixent® accepted for priority review this year, with an sBLA for a 6th indication of uncontrolled COPD in adults accepted in February 2024.

The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects.  The regulator warned that side effects can include conjunctivitis and ulcerative keratitis.