The European Commission has authorized the marketing of a flagship drug from Sanofi for the treatment of smoker’s bronchitis, with this product (Dupixent) now being indicated for six diseases within the European Union, the pharmaceutical group announced on Wednesday.
“The European Commission is the first regulatory authority in the world” to approve Dupixent as add-on maintenance therapy in adults with uncontrolled chronic obstructive pulmonary disease (COPD), Sanofi said in a statement.
This antibody is also being studied in the United States, Japan and China for the treatment of this inflammatory disease of the bronchi which leads to a progressive deterioration of respiratory function.
“Dupixent is the first new medicine for the treatment of uncontrolled chronic obstructive pulmonary disease (COPD) in more than a decade and a new treatment option for approximately 220,000 adults with this disease in the EU,” Sanofi said.
Dupixent reduces these attacks by at least 30%
This irreversible disease is usually treated with inhaled medications that dilate the airways. They can be combined with corticosteroids to reduce inflammation. The appearance of attacks, called exacerbations, in the progression of the disease is a poor prognosis.
Dupixent reduces these worsening attacks by at least 30% for 52 weeks for patients who have so-called type 2 inflammation and are already subject to triple background treatment (short- and long-acting inhalers often combined with corticosteroids).
An improvement in their respiratory function is observed for up to about one year (52 weeks), according to two phase 3 studies. Linked in more than 70% of cases to smoking in high-income countries, COPD is the third leading cause of death in the world, according to the World Health Organization.
Symptoms include chronic cough, shortness of breath and excessive mucus production. They translate into daily difficulties climbing stairs or tying shoes.
Developed jointly by Sanofi and Regeneron, Dupixent (dupilumab), which accounts for a quarter of the French laboratory’s turnover, is already indicated in five other diseases: atopic dermatitis, asthma, nasal polyposis, prurigo nodularis and eosinophilic esophagitis.