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Sanofi and Regeneron recently announced that the U.
The sBLA is based on the results of a pivotal phase 3 clinical trial (LIBERTY ASTHMA VOYAGE).
In the United States, approximately 75,000 children aged 6-11 suffer from uncontrolled moderate-to-severe asthma, which may bring a heavy burden to children and their families.
The results of the LIBERTY ASTHMA VOYAGE study show that Dupixent has the potential to become a best-in-class treatment option for children with asthma from 6 to 11 years old.
LIBERTY ASTHMA VOYAGE is a randomized, double-blind, placebo-controlled trial that enrolled 408 uncontrolled children with moderate to severe asthma (6 years to under 12 years old), and evaluated the addition of Dupixent to labeled care maintenance Efficacy and safety of therapy (medium-dose inhaled corticosteroids [ICS] combined with the second control drug, or: high-dose ICS combined with or without the second drug).
During the 52-week treatment period, patients received a subcutaneous injection of Dupixent 100 mg or 200 mg every 2 weeks (body weight ≤ 30 kg: 100 mg, body weight> 30 kg: 200 mg) according to their body weight, or a subcutaneous injection of placebo every 2 weeks.
The primary endpoint assesses the annualized rate of severe asthma attacks in two main pre-specified populations: patients with EOS ≥ 300 cells/μl in blood at baseline and patients with type 2 inflammatory markers (FeNO ≥ 20 ppb or EOS ≥ 150 cells) /Μl).
-Reduced rate of severe asthma attacks: Compared with placebo, an average reduction of 65% (p<0.
——Improvement of lung function: According to the predicted forced expiratory volume per second (FEV1) percentage (FEV1pp), at week 12, Dupixent treatment improved lung function by 10.
-The safety results of Dupixent in the trial are consistent with the known safety in patients with moderate to severe asthma 12 years of age and older.
Dupixent targets the key drivers of type 2 inflammation.
Dupixent was launched at the end of March 2017 and has been approved to treat 3 types of diseases caused by type 2 inflammation: moderate to severe atopic dermatitis (patients ≥ 6 years old), moderate to severe asthma (patients ≥ 12 years old), Chronic rhinosinusitis with nasal polyps (CRSwNP, adult patients).
In China, in June 2020, Dupixent was approved by the National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis (AD) in adults.
At present, Sanofi and Regeneron are also carrying out an extensive clinical project to evaluate Dupixent in the treatment of diseases caused by allergies and other type 2 inflammations, including: childhood asthma (6-11 years old, stage III), childhood atopy Dermatitis (6 months to 5 years, stage II/III), eosinophilic esophagitis (stage III), chronic obstructive pulmonary disease (stage III), bullous pemphigoid (stage III), prurigo nodularis ( Stage III), chronic spontaneous urticaria (stage III), food and environmental allergies (stage II).
Dupixent is another important product jointly developed by Sanofi and Regeneron following the PCSK9 inhibitor lipid-lowering drug Praluent.
Original source: FDA ACCEPTS DUPIXENT? (DUPILUMAB) FOR REVIEW IN CHILDREN WITH MODERATE-TO-SEVERE ASTHMA
