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Home / News / BioBlast®

EXPLORE OUR

BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: dupilumab

2024

May 31, 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. 

May 20, 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 reviewtheir sBLA for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). 

May 13, 2024

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.

February 29, 2024

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

February 23, 2024

On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®’s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target action date for the FDA decision is 27 June 2024.  Priority review was granted following positive results from two phase 3 trials. Notably, if approved, Dupixent® would be the first new treatment for COPD in over a decade and the only biologic for this disease. 

February 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   

 

 

 

 

 

 

 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

February 16, 2024

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy.  Approval followed a phase 3 trial showing Dupixent® significantly reduced itch severity compared to placebo.  

Last month, FDA approved a new indication of Dupixent® (dupilumab) for the treatment of paediatric patients with eosinophilic esophagitis. 

February 12, 2024

Takeda announced it received approval for EOHILIA ® (budesonide oral suspension) for children aged 11 and older with eosinophilic esophagitis (EoE).  Notably, Dupixent® (dupilumab) was approved to treat children with EoE aged 12 and older in May 2022.  

February 8, 2024

A Sanofi and Regeneron study published on 11 December 2023 found that dupilumab (compared to placebo) significantly improved lung function in children with uncontrolled asthma. The study was randomised with subjects aged between 6-12 years, and the results showed that by week 12, a higher proportion of patients achieved a clinically meaningful response.

On 25 January 2024, Regeneron and Sanofi announced that the FDA approved Dupixent® (dupilumab) to treat paediatric patients, aged 1 to 11 years and weighing at least 15 kg, with eosinophilic esophagitis (EoE).

January 25, 2024

Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to 11 years (weighing at least 15 kg) with eosinophilic esophagitis (EoE).  Dupixent® is the first and only medicine approved in the US to treat these patients.  It was approved to treat EoE patients 12 years and older in May 2022.

On 6 May 2023, a Regeneron-sponsored study concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of EoE.

January 16, 2024

Regeneron and Sanofi announced that the FDA has updated the Dupixent® (dupilumab) label to include efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement.  The new data has also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.  The data is from the first and only trial evaluating a biologic specifically for this difficult-to-treat population.

On 27 November 2023, Sanofi and Regeneron announced they plan to file a supplemental biologics licence application with the FDA for Dupixent® to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.

2023

November 27, 2023

Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.  This application will be based on two phase III clinical trials.

On 20 October 2023, Sanofi and Regeneron received a complete response letter from the FDA regarding its sBLA for Dupixent® for its use in chronic spontaneous urticaria.

October 20, 2023

Regeneron and Sanofi announced that that FDA has issued a Complete Response Letter (CRL) regarding the sBLA for Dupixent® (dupilumab) for use in chronic spontaneous urticaria (CSU).  Regeneron and Sanofi said FDA’s CRL requires additional efficacy data to support an approval, but did not identify any issues with safety or manufacturing.  The companies confirmed that the ongoing clinical trial is enrolling patients, and results are expected in late 2024.  According to Regeneron and Sanofi, these trials should provide the additional efficacy data required by the FDA.

On 11 July 2023 Sanofi received MA for Dupixent® in India to treat moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.

July 11, 2023

Sanofi Healthcare India announced it has received marketing approval for Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.  This is the first biologic treatment for this indication approved in India.  

On 21 May 2023 Sanofi and Regeneron announced positive results from their phase III Dupixent® study in COPD patients with chronic obstructive pulmonary disease. 

May 21, 2023

A study published in the New England Journal of Medicine has found that patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received Dupixent® (dupilumab) had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms than those who received the placebo.  The results of this phase III, double-blind randomised trial were simultaneously announced at the 2023 American Thoracic Society (ATS) International Conference.

The study was sponsored by Sanofi with Regeneron as collaborator.

May 6, 2023

A Regeneron-sponsored study presented at Digestive Disease Week 2023 in Chicago concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of eosinophilic esophagitis (EoE).  Dupilumab was effective regardless of whether adolescent and adult patients had a history of dilation, and improved outcomes for primary and key secondary efficacy endpoints.

Last week Health Canada issued a Notice of Compliance for Sanofi’s Dupixent® (dupilumab) for the treatment of patients over 12 with EOE.

May 5, 2023

A study published in the Journal of Allergy and Clinical Immunology: In Practice reports that Dupilumab holds promise for adults and adolescents with moderate to severe atopic hand and foot dermatits.

This comes 6 years after the FDA approved Dupixent® (dupilumab) for atopic dermatitis.

May 4, 2023

Sanofi announced that Health Canada has issued a Notice of Compliance for Dupixent® (dupilumab) for the treatment of patients over 12 with eosinophilic oesophagitis (EOE).  EoE is a chronic, progressive inflammatory disease that damages the oesophagus.  This is the eighth indication for Dupixent® on label in Canada and the first in gastroenterology.

Two weeks ago Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis.

April 20, 2023

Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® (dupilumab) as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or not advisable.

This comes weeks after Sanofi/Regeneron announced European Commission approval of Dupixent® on 21 March 2023 for the same age group.

March 21, 2023

Regeneron and Sanofi announced European Commission approval of Dupixent® (dupilumab) for the treatment of children aged six months to five years old with severe atopic dermatitis.  Dupilumab is the only targeted medicine to treat this condition in young children approved in Europe and the US.  The approval was based on data from a phase III clinical trial published in the Lancet.

This comes after Regeneron and Sanofi recently announced that the FDA accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.

March 7, 2023

Sanofi and Regeneron announced that the FDA has accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.  The FDA’s decision is expected on 22 October 2023.  The sBLA relied on data from two phase III trials (LIBERTY-CUPID Studies A and B). 

Sanofi also recently announced that it received EC approval for Dupixent® as the first and only targeted medicine indicated for eosinophilic esophagitis in the EU.  

March 1, 2023

The November 2022 PBAC meeting has recommended the following biologics for PBS listing:

  • Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatitis and uncontrolled severe asthma in patients aged 12 years and older.
  • Merck’s pembrolizumab (Keytruda®) for the treatment of persistent, recurrent, or metastatic (Stage IVB) squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma of the cervix in patients whose tumours express PD-L1 combined positive score equal to or greater than 1. This is further to pre-existing listing for unresectable Stage III or Stage IV malignant melanoma, resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma, relapsed or refractory Hodgkin lymphoma, Stage IV (metastatic) non-small cell lung cancer, locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer, relapsed or refractory primary mediastinal B-cell lymphoma, unresectable or metastatic deficient mismatch repair colorectal cancer and recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx.
  • Pfizer’s pneumococcal polysaccharide conjugate vaccine, for the prevention of pneumococcal disease in individuals with an at-risk condition (≥ 18 years), non-Indigenous adults aged ≥ 70 years and Aboriginal and Torres Strait Islander adults aged ≥ 25 years. This was the first submission of the vaccine for the proposed vaccination populations.
  • AbbVie’s risankizumab (Skyrizi®) (which was on the July 2022 PBAC meeting agenda but a decision was deferred to November 2022) to treat adults with severe Crohn’s disease, who have failed to achieve an adequate response, or are contraindicated, to prior systemic therapy, further to pre-existing listing for treatment for severe chronic plaque psoriasis

February 26, 2023

The phase III trial LIBERTY-EoE-TREET examined eosinophilic esophagitis patients treated with duplimab. The authors found that patients had improved histologic, symptomatic, and endoscopic results and the treatment was well tolerated. One of the authors Professor Evan Dellon presented a subanalysis of the data at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting in San Antonio, Texas. Professor Dellon said in an interview that his research “suggests that the medication is biologically active and working on these mechanisms, or we think it would work.”

We have previously reported on the use of dipilumab for atopic dermatitis.

January 30, 2023

The EC approved Sanofi’s Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).  Dupixent is the first medicine specifically indicated to treat EoE in Europe and the US.

2022

December 15, 2022

Regeneron and Sanofi announced that the EC has expanded  the marketing authorisation for Dupixent® (dupilumab) in the EU to include adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.  Dupixent is the only targeted medicine to treat prurigo nodularis approved in Europe and the US.

November 29, 2022

The MHRA updated its guidance on Dupixent® (dupilumab), warning of the risk of ocular adverse reactions.  The MHRA reported that the potential for ocular adverse reactions was established during clinical trials, however further ocular adverse reactions have been identified during post-marketing clinical use.

November 11, 2022

The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

November 4, 2022

A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.

April 4, 2022

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).

February 22, 2022

Bio-Thera provided an update on its pipeline at the BioPharmaSynergy conference in Amsterdam, reporting that its dupilumab, secukinumab, mepolizumab and vedolizumab biosimilars are in preclinical development.

February 10, 2022

Sanofi announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.  Dupixent was first approved by the FDA in March 2017.

2019

June 27, 2019

The CHMP recommended an extension of the approval of Dupixent® (dupilumab) to also include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent was first approved by the EC in September 2017.

2017

September 28, 2017

Sanofi announced that the EC has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis who are candidates for systemic therapy.  Dupixent was approved by the FDA in March 2017.

May 1, 2017

Plaintiffs Sanofi and Regeneron filed a notice of voluntary dismissal, discontinuing without prejudice the proceedings they commenced in the District Court of Massachusetts in March 2017 in which they were seeking a declaration of non-infringement in relation to Amgen’s Dupixent patent.

March 28, 2017

Sanofi and Regeneron announced that the FDA has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

March 23, 2017

Sanofi and Regeneron filed a petition against Immunex, requesting an inter partes review (IPR) of patent 8,679,487.  The petitioners argue that the ‘487 patent is invalid on novelty grounds.  Earlier this month Sanofi and Regeneron filed a complaint in the District Court of Massachusetts, seeking a declaration of non-infringement.

March 20, 2017

Sanofi-Aventis, Genzyme Corporation and Regeneron filed a complaint in the District Court of Massachusetts seeking a declaration judgement that its development, manufacturing, sale, promotion and related activities for Dupixent® (dupilumab) do/will not directly or indirectly infringe Amgen’s US patent 8,679,487.

2016

December 15, 2016

The results of two Regeneron ph III studies published in the New England Journal of Medicine report that dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, improved the signs and symptoms of atopic dermatitis, symptoms of anxiety and depression, and quality of life, compared with placebo.

BioBlast® extract From December 15, 2016 to May 31, 2024