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EU approves Sanofi's Dupixent for 'smoker's lungs'
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EU approves Sanofi's Dupixent for 'smoker's lungs'
Jul 2, 2024 10:31 PM

July 3 (Reuters) - Sanofi and partner

Regeneron on Wednesday won European Union approval for

wider use of their Dupixent injection in patients with a chronic

lung disease, a rare case of the EU clearing a drug faster than

the United States.

The EU Commission approved Dupixent to treat chronic

obstructive pulmonary disease (COPD) in patients that cannot be

helped by standard inhaled drugs, Sanofi said in a statement,

following a recommendation by the European Medicines Agency

(EMA) at the end of May.

The debilitating disease is also known as 'smoker's lungs'

because in western countries it primarily affects cigarette

smokers.

For its part, the U.S. Food and Drug Administration (FDA) in

May pushed back the deadline for reviewing Dupixent in COPD by

three months to Sept. 27 as it demanded additional efficacy

data.

The potentially deadly disease, which causes restricted

airflow and breathing problems, affects nearly 16 million U.S.

adults and over 35 million people in Europe, according to

government data.

French drugmaker Sanofi said in April it expects the target

patient population eligible for the drug to be roughly 300,000

patients in the U.S. alone.

In Europe, the final decision rests with the European

Commission, which usually follows EMA's guidance.

The drug is already approved in many countries for various

immune system-related conditions like asthma and eczema.

Sanofi reported 10.7 billion euros in 2023 Dupixent

revenues, which includes Regeneron's share, and has forecast

about 13 billion euros for this year.

($1 = 0.9215 euros)

(Reporting by Ludwig Burger;

Editing by GV De Clercq)

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