Dupixent, a drug developed by Sanofi and Regeneron, has received approval from the US Food and Drug Administration (FDA) to treat a chronic lung disease known as Chronic obstructive pulmonary disease (COPD),the companies said in a statement.
With the approval, Dupixent also known as Dupilumab has become the first biologic medicine in US to treat patients suffering from COPD.
The health regulatory body gave green signal after analyzing data from two phase 3 trials (BOREAS and NOUS) involving a total of 1,874 COPD patients aged between 40 and 85. Treatment with Dupixent was associated with 30 percent(BOREAS)and 34 percent(NOUS) reduction in COPD exacerbations, the French drugmaker said. Treatment with Dupixent also helped improve lung function and quality of lifeinpatients.
COPD is the third leading cause of death across the world.Patients with COPD will have damaged lungs, often clogged with phlegm, which affects the normal airflow and breathing.
Long term exposure to smoke, fumes, duct or chemicals play a huge role in COPD, according to the Mayo clinic.Tobacco smoking account for about 70 percent of COPD cases, according to The World Health Organization (WHO).Symptoms include persistent cough, wheezing, shortness of breath and fatigue.
Findings of the two studies,published in The New England Journal of Medicine, are expected to help improve the lives of more than 300,000 people affected by COPD in US.
"With today's approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations,"Paul Hudson, Chief Executive Officer, Sanofisaid.
Dupixent,which has been approved in more than 60 countries across the world for treating different health conditions, generated 10.72 billion euros ($11.94 billion) in sales in 2023, according to Reuters.Referring to the predictions from some analysts, the news agency added that the drugwhich treats more than 1,000,000 patients globallywill generate a revenue of 21 billion euros by 2030.
A forecast fromEvaluate had earlier listed Dupixent,which was first approved for treating atopic dermatitis (eczema) in 2017, among the top three drugs in 2028.
Dupixent, so far, hasbeen used to treat atopic dermatitis, asthma, swelling of sinus and nasal cavity calledchronic rhinosinusitis, eosinophilic esophagitis (EoE), skin condition prurigo nodularis and chronic spontaneous urticaria(CSU).
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