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)