India Pharma Outlook Team | Thursday, 04 July 2024
Sanofi and Regeneron received European Union permission for the expanded use of their Dupixent injection in patients with chronic lung disease, a rare instance of the EU clearing a medicine faster than the United States.
The EU Commission authorized Dupixent to treat chronic obstructive pulmonary disease (COPD) in patients who cannot be assisted by traditional inhaled medications, Sanofi said in a statement, after a recommendation from the European Medicines Agency (EMA) at the end of May.
The disabling condition is often known as'smoker's lungs' since it mostly affects cigarette smokers in Western countries. In May, the United States Food and Drug Administration (FDA) pushed up the deadline for examining Dupixent in COPD by three months to September 27 in order to obtain further efficacy data.
According to government data, almost 16 million adults in the United States and over 35 million people in Europe suffer with the potentially fatal condition, which causes limited airflow and breathing issues. In April, manufacturing firm, Sanofi stated that the target patient group eligible for the treatment will be approximately 300,000 in the United States alone.
In Europe, the European Commission makes the final decision, which normally follows the EMA's guidelines. Many nations have previously licensed the medicine to treat a variety of immune system diseases, including asthma and eczema.