Dupixent® (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation

  • Dupixent is the only biologic indicated in the European Union for severe asthma with type 2 inflammation, characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide  
  • Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children
  • Data reinforce well-established safety profile of Dupixent

 The European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Asthma is one of the most common habitual conditions in children. Up to 85 of children with asthma may have type 2 inflammation and are more likely to have advanced complaint burden. Despite treatment with current standard-of- care ICS and bronchodilators, these children may continue to witness serious symptoms similar as coughing, gasping and difficulty breathing. Severe asthma may impact children’s developing airways and beget potentially life- hanging exacerbations. Children with severe asthma also may bear the use of multiple courses of systemic corticosteroids that carry significant pitfalls. Unbridled severe asthma can intrude with day-to- day conditioning, like sleeping, attending academy and playing sports.
Dupixent is a completely mortal monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and isn’t an immunosuppressant. The Dupixent Phase 3 clinical program, which has shown significant clinical benefit and a drop in type 2 inflammation, has established that IL-4 and IL-13 are crucial and central motorists of the type 2 inflammation that plays a major part in in multiple affiliated and frequentlyco-morbid conditions.

Mainly reduced rates of severe asthma attacks, with a 65 and 59 average reduction over one time compared to placebo (0.24 and0.31 events per time for Dupixentvs.0.67 and0.75 for placebo, independently).
Bettered lung function observed as early as two weeks and sustained for over to 52 weeks, measured by percent prognosticated FEV1 (FEV1pp).
At 12 weeks, cases taking Dupixent bettered their lung function by5.32 and5.21 chance points compared to placebo, independently.

About the LIBERTY ASTHMA Passage Trial
The Phase 3 randomized, double-eyeless, placebo- controlled trial estimated the efficacity and safety of Dupixent (100 mg or 200 mg every two weeks, grounded on weight league) combined with standard-of- care asthma remedy in 408 children progressed 6 to 11 times with unbridled moderate-to-severe asthma. Further than 90 of children in the trial had at least one concurrent atopic medical condition similar as antipathetic rhinitis and atopic dermatitis.

The primary endpoint was the annualized rate of severe asthma exacerbations over one time, and the crucial secondary endpoint was the change from birth in chance of prognosticatedpre-bronchodilator FEV1 (FEV1pp) at week 12. The FEV1pp seeks to estimate a case’s change in lung function compared to their prognosticated lung function grounded on age, height, coitus and race to regard for children’s growing lung capacity at different stages of development. Fresh secondary endpoints included pollee rates for asthma control as measured by a ≥0.5 enhancement on the Asthma Control Questionnaire-7 Canvasser Administered (ACQ-7-IA; 7- point scale) and health- related quality of life as measured by a ≥0.5 enhancement on the Pediatric Asthma Quality of Life Questionnaire with Formalized Conditioning- Canvasser Administered (PAQLQ (S)-IA; 7- point scale).
About Dupixent

Dupixent is also approved in Europe,U.S., Japan and other countries around the world for use in certain cases with asthma, specific cases with moderate-to-severe atopic dermatitis as well as CRSwNP in different age populations. Dupixent is also approved in one or further of these suggestions in further than 60 countries around the world, and further than cases have been treated encyclopedically.
Dupixent is an injection under the skin (subcutaneous injection) at different injection spots. In the EU for pediatric cases progressed 6 to 11 times, Dupixent dosing is grounded on weight league (100 mg every two weeks or 300 mg every four weeks for children ≥ 15 to< 30 kg, 200 mg every two weeks or 300 mg every four weeks for children ≥ 30 to< 60 kg and 200 mg every two weeks for children ≥ 60 kg) and is supplied as apre-filled hype. It’s also available as apre-filled pen for adolescents (12 to 17 times) and grown-ups at 200 and 300 mg boluses. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by tone- administration after training by a healthcare professional. In children youngish than 12 times of age, Dupixent should be administered by a caregiver if given at home.

About Sanofi
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