Sanofi’s Dupixent Injectable Approved by the EU to Treat Chronic Lung Disease

Sanofi and Regeneron gained approval from the European Union for expanded use of the Dupixent injection in patients suffering from chronic lung disease- a rare instance where the EU authorizes a medication earlier than the United States.

Sanofi is involved in the discovery, synthesis, production, and promotion of medicinal products, primarily focusing on the prescription segment, though it also develops OTC products. The corporation covers seven major therapeutic areas: cardiology, neuroscience, endocrinology, gen-internal medicine, medical oncology, hemostasis and thrombosis, and vaccines.

Regeneron, an independent biotechnology company established in 1988, initially focused on neurotrophic factors and regenerating capabilities, from which its name was derived. The company then diversified into cytokine and tyrosine kinase receptor studies, leading to their first product, VEGF-trap.

Sanofi also received EU approval for another indication of Dulera. The EU Commission authorized this drug to treat chronic obstructive pulmonary disease (COPD) in patients who cannot be relieved by standard inhaled medications.

This debilitating disease, also referred to as ‘smoker’s lungs,’ occurs most often in smokers in Western countries. The US Food and Drug Administration (FDA) in May extended the decision date for Dupixent in COPD by three months to September to gather more efficacy data. This potentially fatal disease, which leads to constriction of the airways and breathing difficulties, affects approximately 15.8 million people in the US.

Sanofi, the French drugmaker, revealed in late April that it anticipated the target patient population eligible for the drug to be approximately 300,000 in the United States alone. In Europe, the final decision lies with the European Commission, which generally follows EMA’s recommendations.

The FDA has already approved the drug in many countries for immune system disorders such as asthma and eczema. Sanofi reported 10.7 billion euros in Dupixent sales, including Regeneron’s share, by 2023. This year, it is estimated to be around 13 billion euros.

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