- EU approves drug to treat chronic lung disease
- First targeted treatment for COPD
- Drug expected to generate €20 billion in sales
French drug maker Sanofi (SAN:EPA) has received European regulatory approval for Dupixent, its asthma and skin drug to treat patients with chronic lung disease.
Dupixent is the first-ever targeted therapy for COPD (chronic obstructive pulmonary disease), known as ‘smoker’s cough’ since it mainly affects cigarette smokers.
COPD restricts airflow and affects over 35 million people in Europe and nearly 16 million people in the US.
The approval follows two landmark late-stage clinical studies which showed Dupixent improved lung function and improved quality of life for patients suffering from COPD.
Dupixent was co-developed with US-listed Regeneron Pharmaceuticals (REGN:NASDAQ) and is already approved in several countries for treating immune-system related diseases and eczema, a type of skin disease.
Sanofi shares traded up slightly to €90.45 on the news, while Regeneron shares open later in the US.
WHAT DID THE COMPANY SAY?
Sanofi CEO Paul Hudson commented: ‘Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function.
‘With today’s approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils.
‘We look forward to working with other regulators around the world as quickly as possible to bring this novel treatment approach to patients in more countries.’
WHAT IS THE FINANCIAL POTENTIAL?
The drug generated €10.7 billion of revenue in 2023, including Regeneron’s share, and analysts forecast sales around €13 billion in 2024. According to analyst estimates compiled by Bloomberg, revenue could grow to more than €20 billion by the end of the decade.
For once the European regulators have acted ahead of the US with the FDA (Food and Drug Administration) expected to make a final decision by the end of September 2024.
