BioBlast®

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.

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.  

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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

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.